Trial Outcomes & Findings for The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study) (NCT NCT03783039)

Last Updated: 2021-07-08

Results Overview

Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure

Recruitment status

COMPLETED

Study phase

Target enrollment

234 participants

Primary outcome timeframe

From product application to 5 minutes following product application

Results posted on

2021-07-08

Participant Flow

Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.

Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine.

Participant milestones

Participant milestones
Measure	SURGICEL Powder SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original Absorbable Hemostat (Oxidized Regenerated Cellulose)
Overall Study STARTED	119	115
Overall Study COMPLETED	117	114
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SURGICEL Powder SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original Absorbable Hemostat (Oxidized Regenerated Cellulose)
Overall Study Death	2	1

Baseline Characteristics

The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SURGICEL Powder n=119 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)	Total n=234 Participants Total of all reporting groups
Age, Continuous	54.0 Years n=99 Participants	52.0 Years n=107 Participants	53.0 Years n=206 Participants
Sex: Female, Male Female	77 Participants n=99 Participants	73 Participants n=107 Participants	150 Participants n=206 Participants
Sex: Female, Male Male	42 Participants n=99 Participants	42 Participants n=107 Participants	84 Participants n=206 Participants
Race/Ethnicity, Customized Han	116 Participants n=99 Participants	114 Participants n=107 Participants	230 Participants n=206 Participants
Race/Ethnicity, Customized Other	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants

PRIMARY outcome

Timeframe: From product application to 5 minutes following product application

Population: Per Protocol Analysis (All intent to treat subjects who have no major protocol deviations and have data available for primary effectiveness endpoint)

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=114 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)
Hemostatic Success at 5 Minutes	109 Participants	103 Participants

SECONDARY outcome

Timeframe: From product application to 3 minutes following product application

Population: Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)

Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=119 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)
Hemostatic Success at 3 Minutes	107 Participants	92 Participants

SECONDARY outcome

Timeframe: From product application to 10 minutes following product application

Population: Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)

Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=119 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)
Hemostatic Success at 10 Minutes	114 Participants	107 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to 30-day follow-up visit

Population: Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)

Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=119 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)
Number of Participants With Thromboembolic Events Investigator Assessment	0 Participants	0 Participants
Number of Participants With Thromboembolic Events Sponsor Assessment	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From initiation of final fascial closure to 30-day follow-up visit

Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=119 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)
Number of Participants With Post-operative Re-bleeding Events Investigator Assessment	1 Participants	1 Participants
Number of Participants With Post-operative Re-bleeding Events Sponsor Assessment	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to 6 month follow up visit

Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment

Outcome measures

Outcome measures
Measure	SURGICEL Powder n=119 Participants SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 Participants Absorbable Hemostat (Oxidized Regenerated Cellulose)
Number of Participants With Serious Adverse Events Requiring Surgical Intervention	0 Participants	0 Participants

Adverse Events

SURGICEL Powder

Serious events: 9 serious events

Other events: 83 other events

Deaths: 2 deaths

SURGICEL Original

Serious events: 5 serious events

Other events: 80 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Patricia Schleckser

ETHICON, Inc

Phone: 01 908 218 2244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal investigator and institution will not be able to publish single-center study data until combined results of the multicenter study are published. If multicenter publication is not performed within 12 months after the end or if sponsor notifies principal investigator and institution in writing that the multicenter study results will not be published, the principal investigator and institution may publish the results of their studies separately in accordance with contract.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	SURGICEL Powder n=119 participants at risk SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 participants at risk Absorbable Hemostat (Oxidized Regenerated Cellulose)
Gastrointestinal disorders Abdominal Pain	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Gastrointestinal Hemorrhage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Hemorrhagic Ascites	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Intra-abdominal Hemorrhage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Peritoneal Hemorrhage	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pulmonary Air Leakage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Anastomotic Fistula	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Post Procedural Bile Leak	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Post Procedural Hemorrhage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Liver Abscess	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Infections and infestations Post Procedural Infection	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Nervous system disorders Cerebral Infarction	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Nervous system disorders Hemorrhage Intracranial	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Shock Hemorrhagic	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Vascular disorders Venous Thrombosis Limb	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Congenital, familial and genetic disorders Hemophilia	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Psychiatric disorders Insomnia	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.

Other adverse events
Measure	SURGICEL Powder n=119 participants at risk SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)	SURGICEL Original n=115 participants at risk Absorbable Hemostat (Oxidized Regenerated Cellulose)
Injury, poisoning and procedural complications Incision Site Pain	27.7% 33/119 • Number of events 34 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	22.6% 26/115 • Number of events 28 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Incision Site Complication	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Procedural Hypertension	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Anaemia postoperative	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Incision Site Hemorrhage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Pancreatic Leak	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Post Procedural Discharge	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Post Procedural Fever	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Injury, poisoning and procedural complications Wound Complication	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Vomiting	6.7% 8/119 • Number of events 8 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	5.2% 6/115 • Number of events 6 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal Distension	5.0% 6/119 • Number of events 6 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	5.2% 6/115 • Number of events 6 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Constipation	3.4% 4/119 • Number of events 4 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	7.0% 8/115 • Number of events 8 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal Pain	5.9% 7/119 • Number of events 9 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	2.6% 3/115 • Number of events 3 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Nausea	5.9% 7/119 • Number of events 7 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	3.5% 4/115 • Number of events 4 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Dyschezia	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	2.6% 3/115 • Number of events 3 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal Discomfort	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Diarrhoea	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	1.7% 2/115 • Number of events 2 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Flatulence	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Abdominal Tenderness	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Anal Hemorrhage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Appendicitis Noninfective	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Chronic Gastritis	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Dysbacteriosis	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Impaired Gastric Emptying	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Mouth Hemorrhage	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Pancreatic Fistula	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Gastrointestinal disorders Retching	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Acute Phase Reaction	11.8% 14/119 • Number of events 14 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	10.4% 12/115 • Number of events 13 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Pyrexia	5.9% 7/119 • Number of events 8 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	7.8% 9/115 • Number of events 9 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Asthenia	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
General disorders Oedema Peripheral	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hypokalaemia	7.6% 9/119 • Number of events 9 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	5.2% 6/115 • Number of events 7 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hypoproteinaemia	7.6% 9/119 • Number of events 9 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	4.3% 5/115 • Number of events 5 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Metabolic Acidosis	2.5% 3/119 • Number of events 3 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Decreased Appetite	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	1.7% 2/115 • Number of events 2 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hyponatraemia	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	1.7% 2/115 • Number of events 2 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Hyperkalaemia	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.87% 1/115 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Malnutrition	0.00% 0/119 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	1.7% 2/115 • Number of events 2 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.
Metabolism and nutrition disorders Acidosis	0.84% 1/119 • Number of events 1 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.	0.00% 0/115 • All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure. For this study, an adverse event was any untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.