Trial Outcomes & Findings for A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection (NCT NCT02205307)
NCT ID: NCT02205307
Last Updated: 2020-06-24
Results Overview
Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
347 participants
Primary outcome timeframe
Day 0 to Week 8 (+/- 2 weeks)
Results posted on
2020-06-24
Participant Flow
Participant milestones
| Measure |
PINPOINT or SPY Elite
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
A low anterior resection will be performed according to the surgeon's standard practice
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
169
|
|
Overall Study
COMPLETED
|
161
|
163
|
|
Overall Study
NOT COMPLETED
|
17
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Baseline characteristics by cohort
| Measure |
PINPOINT or SPY Elite
n=178 Participants
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
n=169 Participants
A low anterior resection will be performed according to the surgeon's standard practice
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean
|
57.2 years
STANDARD_DEVIATION 11.14 • n=99 Participants
|
56.5 years
STANDARD_DEVIATION 11.59 • n=107 Participants
|
56.9 years
STANDARD_DEVIATION 11.36 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
7 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
23 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
23 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
123 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Height
|
171.89 cm
STANDARD_DEVIATION 9.814 • n=99 Participants
|
171.32 cm
STANDARD_DEVIATION 9.790 • n=107 Participants
|
171.61 cm
STANDARD_DEVIATION 9.792 • n=206 Participants
|
|
Weight
|
82.49 kg
STANDARD_DEVIATION 19.743 • n=99 Participants
|
83.11 kg
STANDARD_DEVIATION 19.815 • n=107 Participants
|
82.79 kg
STANDARD_DEVIATION 19.752 • n=206 Participants
|
|
Smoking Status
Yes
|
52 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Smoking Status
No
|
126 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
264 Participants
n=206 Participants
|
|
Alcohol Consumption
Yes
|
81 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Alcohol Consumption
No
|
97 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
MELD Score (Model for End-Stage Liver Disease)
|
6.8 units on a scale (6-40)
STANDARD_DEVIATION 1.06 • n=99 Participants
|
6.7 units on a scale (6-40)
STANDARD_DEVIATION 1.36 • n=107 Participants
|
6.8 units on a scale (6-40)
STANDARD_DEVIATION 1.22 • n=206 Participants
|
|
Long-Course Neoadjuvant Therapy
Yes
|
113 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Long-Course Neoadjuvant Therapy
No
|
65 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Pre-Operative Diagnosis
Rectal Cancer
|
144 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Pre-Operative Diagnosis
Rectosigmoid Cancer
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Pre-Operative Diagnosis
Polyp
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Pre-Operative Diagnosis
Other
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Week 8 (+/- 2 weeks)Population: Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.
Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
Outcome measures
| Measure |
PINPOINT or SPY Elite
n=175 Participants
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
n=168 Participants
A low anterior resection will be performed according to the surgeon's standard practice
|
|---|---|---|
|
Anastomotic Leak Rate
Subjects with Post-Operative Anastomotic Leak
|
14 Participants
|
16 Participants
|
|
Anastomotic Leak Rate
Subjects Known to be Anastomotic Leak Free
|
148 Participants
|
148 Participants
|
|
Anastomotic Leak Rate
Unknown/Lost to Follow Up
|
13 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 0 (Day of Surgery)Population: Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.
The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure
Outcome measures
| Measure |
PINPOINT or SPY Elite
n=175 Participants
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
A low anterior resection will be performed according to the surgeon's standard practice
|
|---|---|---|
|
Rate of SPY Visualization and Tissue Perfusion
|
167 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Week 8 (+/- 2 weeks)Population: Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.
Rate of postoperative abscess requiring surgical management.
Outcome measures
| Measure |
PINPOINT or SPY Elite
n=175 Participants
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
n=168 Participants
A low anterior resection will be performed according to the surgeon's standard practice
|
|---|---|---|
|
Incidence of Post-Operative Abscess Requiring Surgical Management
Yes
|
10 Participants
|
7 Participants
|
|
Incidence of Post-Operative Abscess Requiring Surgical Management
No
|
165 Participants
|
161 Participants
|
Adverse Events
PINPOINT or SPY Elite
Serious events: 44 serious events
Other events: 155 other events
Deaths: 3 deaths
STANDARD
Serious events: 52 serious events
Other events: 146 other events
Deaths: 1 deaths
Not Treated
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PINPOINT or SPY Elite
n=171 participants at risk
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
n=168 participants at risk
A low anterior resection will be performed according to the surgeon's standard practice
|
Not Treated
n=8 participants at risk
Not treated by either perfusion (PINPOINT/SPY Elite) or standard treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
2.3%
4/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
4.8%
8/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.3%
4/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Diarrhea
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Functional Gastrointestinal Disorder
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Internal Hernia
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Intra-Abdominal Hemorrhage
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Nausea
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
4.1%
7/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
4.8%
8/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Anastomotic Complication
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Incision Site Erosion
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Stoma Site Haemorrhage
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Ureteric Injury
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Infections and infestations
Pelvic Abscess
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
2.4%
4/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Infections and infestations
Sepsis
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.8%
3/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Infections and infestations
Septic Shock
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
3/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
4.8%
8/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.8%
3/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
1.2%
2/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Renal and urinary disorders
Renal Impairment
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Vascular disorders
Arterial Haemorrhage
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Vascular disorders
Hypertension
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Vascular disorders
Hypotension
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Cardiac disorders
Bradycardia
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Cardiac disorders
Cardiac Failure
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Cardiac disorders
Tachycardia
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Psychiatric disorders
Depression
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Reproductive system and breast disorders
Pelvic Haematoma
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Reproductive system and breast disorders
Pelvic Fluid Collection
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
General disorders
Death
|
1.8%
3/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
General disorders
Multi-organ Failure
|
0.58%
1/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
2/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Surgical and medical procedures
Ileostomy Closure
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Surgical and medical procedures
Small Intestinal Resection
|
0.00%
0/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.60%
1/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
Other adverse events
| Measure |
PINPOINT or SPY Elite
n=171 participants at risk
A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
|
STANDARD
n=168 participants at risk
A low anterior resection will be performed according to the surgeon's standard practice
|
Not Treated
n=8 participants at risk
Not treated by either perfusion (PINPOINT/SPY Elite) or standard treatment.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
36.3%
62/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
36.9%
62/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
12.5%
1/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
5.3%
9/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
7.1%
12/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
4.1%
7/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
6.5%
11/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
45/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
24.4%
41/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
22/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
17.3%
29/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
12.5%
1/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.8%
27/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
8.9%
15/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.0%
12/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
9.5%
16/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
Gastrointestinal disorders
Ileus
|
3.5%
6/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
7.7%
13/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
|
General disorders
Pain
|
12.3%
21/171 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
6.5%
11/168 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
0.00%
0/8 • 8 weeks
Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place