Trial Outcomes & Findings for Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial. (NCT NCT01936948)

NCT ID: NCT01936948

Last Updated: 2024-07-12

Results Overview

A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.

Recruitment status

COMPLETED

Study phase

Target enrollment

928 participants

Primary outcome timeframe

30 days following a study polyp resection

Results posted on

2024-07-12

Participant Flow

Some of the inclusion/exclusion criteria, e.g. polyp size, poor bowel preparation, could not be assessed until after the start of the colonoscopy. Therefore, informed consent was obtained and the patient enrolled in the study prior to the procedure. Only when it was determined that the patient was eligible for the study were they then randomized.

Participant milestones

Participant milestones
Measure	Clip Closure + EndoCut Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	Clip Closure + Coagulation Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure + EndoCut No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.	No Clip Closure + Coagulation No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
Overall Study STARTED	227	231	237	233
Overall Study Crossover	31	27	22	25
Overall Study COMPLETED	227	228	234	230
Overall Study NOT COMPLETED	0	3	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Clip Closure + EndoCut Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	Clip Closure + Coagulation Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure + EndoCut No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.	No Clip Closure + Coagulation No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
Overall Study no 30-day follow-up data	0	3	3	3

Baseline Characteristics

Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clip Closure + EndoCut n=227 Participants Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	Clip Closure + Coagulation n=231 Participants Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure + EndoCut n=237 Participants No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.	No Clip Closure + Coagulation n=233 Participants No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.	Total n=928 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 9.7 • n=99 Participants	65.5 years STANDARD_DEVIATION 9.2 • n=107 Participants	64.8 years STANDARD_DEVIATION 9.8 • n=206 Participants	65.3 years STANDARD_DEVIATION 9.8 • n=157 Participants	65.1 years STANDARD_DEVIATION 9.6 • n=390 Participants
Sex: Female, Male Female	92 Participants n=99 Participants	98 Participants n=107 Participants	96 Participants n=206 Participants	90 Participants n=157 Participants	376 Participants n=390 Participants
Sex: Female, Male Male	135 Participants n=99 Participants	133 Participants n=107 Participants	141 Participants n=206 Participants	143 Participants n=157 Participants	552 Participants n=390 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=157 Participants	7 Participants n=390 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Black or African American	16 Participants n=99 Participants	18 Participants n=107 Participants	11 Participants n=206 Participants	17 Participants n=157 Participants	62 Participants n=390 Participants
Race (NIH/OMB) White	200 Participants n=99 Participants	202 Participants n=107 Participants	214 Participants n=206 Participants	205 Participants n=157 Participants	821 Participants n=390 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=99 Participants	9 Participants n=107 Participants	11 Participants n=206 Participants	9 Participants n=157 Participants	38 Participants n=390 Participants
Body Mass Index (BMI)	29.5 kg/m^2 STANDARD_DEVIATION 6.6 • n=99 Participants	29.0 kg/m^2 STANDARD_DEVIATION 5.6 • n=107 Participants	29.1 kg/m^2 STANDARD_DEVIATION 6.2 • n=206 Participants	29.1 kg/m^2 STANDARD_DEVIATION 5.6 • n=157 Participants	29.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=390 Participants
ASA Class ASA I - normal healthy patient	23 Participants n=99 Participants	17 Participants n=107 Participants	19 Participants n=206 Participants	20 Participants n=157 Participants	79 Participants n=390 Participants
ASA Class ASA II - patient with mild systemic disease	125 Participants n=99 Participants	133 Participants n=107 Participants	134 Participants n=206 Participants	121 Participants n=157 Participants	513 Participants n=390 Participants
ASA Class ASA III - patient with severe systemic disease	79 Participants n=99 Participants	81 Participants n=107 Participants	84 Participants n=206 Participants	92 Participants n=157 Participants	336 Participants n=390 Participants
Periprocedural Antithrombic Medications Antiplatelet agents	54 Participants n=99 Participants	47 Participants n=107 Participants	61 Participants n=206 Participants	70 Participants n=157 Participants	232 Participants n=390 Participants
Periprocedural Antithrombic Medications Anticoagulants	5 Participants n=99 Participants	15 Participants n=107 Participants	13 Participants n=206 Participants	16 Participants n=157 Participants	49 Participants n=390 Participants
Periprocedural Antithrombic Medications None	168 Participants n=99 Participants	169 Participants n=107 Participants	163 Participants n=206 Participants	147 Participants n=157 Participants	647 Participants n=390 Participants
Procedure Sedation No Sedation	1 Participants n=99 Participants	4 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=157 Participants	6 Participants n=390 Participants
Procedure Sedation Moderate Sedation	32 Participants n=99 Participants	26 Participants n=107 Participants	33 Participants n=206 Participants	25 Participants n=157 Participants	116 Participants n=390 Participants
Procedure Sedation Monitored Anesthesia	194 Participants n=99 Participants	201 Participants n=107 Participants	204 Participants n=206 Participants	207 Participants n=157 Participants	806 Participants n=390 Participants
Quality of Bowel Preparation Excellent	62 Participants n=99 Participants	64 Participants n=107 Participants	55 Participants n=206 Participants	68 Participants n=157 Participants	249 Participants n=390 Participants
Quality of Bowel Preparation Good	123 Participants n=99 Participants	133 Participants n=107 Participants	146 Participants n=206 Participants	127 Participants n=157 Participants	529 Participants n=390 Participants
Quality of Bowel Preparation Fair	42 Participants n=99 Participants	34 Participants n=107 Participants	36 Participants n=206 Participants	38 Participants n=157 Participants	150 Participants n=390 Participants
Electrocautery Forced Coagulation	0 Participants n=99 Participants	228 Participants n=107 Participants	0 Participants n=206 Participants	230 Participants n=157 Participants	458 Participants n=390 Participants
Electrocautery EndoCut	227 Participants n=99 Participants	0 Participants n=107 Participants	234 Participants n=206 Participants	0 Participants n=157 Participants	461 Participants n=390 Participants
Electrocautery None - did not complete study	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=157 Participants	9 Participants n=390 Participants
Additional Polyps (any size) Yes	98 Participants n=99 Participants	103 Participants n=107 Participants	103 Participants n=206 Participants	104 Participants n=157 Participants	408 Participants n=390 Participants
Additional Polyps (any size) No	129 Participants n=99 Participants	128 Participants n=107 Participants	134 Participants n=206 Participants	129 Participants n=157 Participants	520 Participants n=390 Participants
More Than One Study Polyp Yes	19 Participants n=99 Participants	10 Participants n=107 Participants	21 Participants n=206 Participants	11 Participants n=157 Participants	61 Participants n=390 Participants
More Than One Study Polyp No	208 Participants n=99 Participants	221 Participants n=107 Participants	216 Participants n=206 Participants	222 Participants n=157 Participants	867 Participants n=390 Participants

PRIMARY outcome

Timeframe: 30 days following a study polyp resection

Population: As per study protocol, the primary analysis was done using clip/no clip closure as the study groups. Data for 9 patients was not available.

Outcome measures

Outcome measures
Measure	Clip Closure n=455 Participants Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure n=464 Participants No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode.
Number of Participants With Delayed Bleeding Complications	16 Participants	33 Participants

SECONDARY outcome

Timeframe: 30 days

Overall complications are defined as an aggregate of all complications that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. They include delayed bleeding complications, perforation, postpolypectomy syndrome, and clinical events that require an ED visit, admission to the hospital, additional testing or an intervention.

Outcome measures

Outcome measures
Measure	Clip Closure n=455 Participants Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure n=464 Participants No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode.
The Overall Number of Complications	22 Participants	44 Participants

Adverse Events

Clip Closure + EndoCut

Serious events: 11 serious events

Other events: 34 other events

Deaths: 0 deaths

Clip Closure + Coagulation

Serious events: 11 serious events

Other events: 20 other events

Deaths: 0 deaths

No Clip Closure + EndoCut

Serious events: 21 serious events

Other events: 33 other events

Deaths: 2 deaths

No Clip Closure + Coagulation

Serious events: 23 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clip Closure + EndoCut n=227 participants at risk Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	Clip Closure + Coagulation n=228 participants at risk Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure + EndoCut n=234 participants at risk No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.	No Clip Closure + Coagulation n=230 participants at risk No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
Surgical and medical procedures Postprocedure hemorrhage	2.6% 6/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	4.4% 10/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	6.8% 16/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	7.4% 17/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Surgical and medical procedures Intraprocedural bleeding	0.44% 1/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Surgical and medical procedures Abdominal Pain	0.00% 0/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.44% 1/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Surgical and medical procedures Perforation	1.3% 3/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	1.3% 3/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	1.3% 3/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Gastrointestinal disorders Postpolypectomy syndrome	0.44% 1/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
General disorders Other	0.00% 0/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.

Other adverse events

Other adverse events
Measure	Clip Closure + EndoCut n=227 participants at risk Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	Clip Closure + Coagulation n=228 participants at risk Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.	No Clip Closure + EndoCut n=234 participants at risk No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.	No Clip Closure + Coagulation n=230 participants at risk No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
Gastrointestinal disorders Abdominal Pain	4.8% 11/227 • Number of events 11 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	4.4% 10/228 • Number of events 10 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	4.7% 11/234 • Number of events 11 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	3.0% 7/230 • Number of events 7 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Gastrointestinal disorders Bleeding	6.6% 15/227 • Number of events 15 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	2.2% 5/228 • Number of events 5 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	6.8% 16/234 • Number of events 16 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	7.0% 16/230 • Number of events 16 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
General disorders Blood pressure problems	0.88% 2/227 • Number of events 2 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Gastrointestinal disorders Bowel movement problems	1.3% 3/227 • Number of events 3 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.44% 1/228 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/234 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.87% 2/230 • Number of events 2 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Renal and urinary disorders Urinary issues	0.44% 1/227 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/228 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.85% 2/234 • Number of events 2 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/230 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Cardiac disorders Cardiovascular event	0.00% 0/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.44% 1/228 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/234 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
General disorders Headaches/Fevers	0.44% 1/227 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	1.8% 4/228 • Number of events 4 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	1.3% 3/234 • Number of events 3 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/230 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
General disorders Other	2.6% 6/227 • Number of events 6 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	2.2% 5/228 • Number of events 5 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	1.3% 3/234 • Number of events 3 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.87% 2/230 • Number of events 2 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
Gastrointestinal disorders Post-polypectomy syndrome	0.00% 0/227 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.44% 1/228 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.43% 1/234 • Number of events 1 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.	0.00% 0/230 • Within 30 days of the colonoscopy. Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.

Additional Information

Heiko Pohl

White River Junction VA Medical Center

Phone: 802-295-9363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place