Trial Outcomes & Findings for Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping (NCT NCT01647581)
NCT ID: NCT01647581
Last Updated: 2019-10-15
Results Overview
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11182 participants
Primary outcome timeframe
30 days
Results posted on
2019-10-15
Participant Flow
11,182 enrolled into the study, but 10,084 screen failures as the majority did not have a polyp 1cm in size to meet criteria for randomization
Must have polyp 1cm in size removed during colonoscopy
Participant milestones
| Measure |
Clip
A clip is been placed at the polypectomy site.
Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size
|
No Clip
A hemoclip is not placed at the site of the polypectomy.
NO hemoclip placement: No hemoclip placement (placebo / sham)
|
|---|---|---|
|
Overall Study
STARTED
|
547
|
551
|
|
Overall Study
COMPLETED
|
530
|
520
|
|
Overall Study
NOT COMPLETED
|
17
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
Baseline characteristics by cohort
| Measure |
Clip
n=530 Participants
A clip is been placed at the polypectomy site.
Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size
|
No Clip
n=520 Participants
A hemoclip is not placed at the site of the polypectomy.
NO hemoclip placement: No hemoclip placement (placebo / sham)
|
Total
n=1050 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
251 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
279 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
553 Participants
n=5 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
516 Participants
n=5 Participants
|
499 Participants
n=7 Participants
|
1015 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
370 Participants
n=5 Participants
|
375 Participants
n=7 Participants
|
745 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black
|
117 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
42 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
530 Participants
n=5 Participants
|
520 Participants
n=7 Participants
|
1050 Participants
n=5 Participants
|
|
smoking
|
197 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysrectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Outcome measures
| Measure |
Clip
n=530 Participants
A clip is been placed at the polypectomy site.
Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size
|
No Clip
n=520 Participants
A hemoclip is not placed at the site of the polypectomy.
NO hemoclip placement: No hemoclip placement (placebo / sham)
|
|---|---|---|
|
Number of Patients With Delayed Post Polypectomy Bleeding
|
12 Participants
|
15 Participants
|
Adverse Events
Clip
Serious events: 25 serious events
Other events: 5 other events
Deaths: 1 deaths
No Clip
Serious events: 21 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Clip
n=547 participants at risk
A clip is been placed at the polypectomy site.
Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size
|
No Clip
n=551 participants at risk
A hemoclip is not placed at the site of the polypectomy.
NO hemoclip placement: No hemoclip placement (placebo / sham)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
2/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Cardiac disorders
Chest pain / bradycardia
|
0.55%
3/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Renal and urinary disorders
Chronic renal failure
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Vascular disorders
Cerebrovascular accident / Deep vein thrombosis
|
0.37%
2/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Surgical and medical procedures
Elective laminectomy
|
0.00%
0/547 • 30 days
|
0.18%
1/551 • 30 days
|
|
Hepatobiliary disorders
Gallstones
|
0.00%
0/547 • 30 days
|
0.18%
1/551 • 30 days
|
|
Injury, poisoning and procedural complications
Post-polypectomy bleed
|
2.2%
12/547 • 30 days
|
2.7%
15/551 • 30 days
|
|
Injury, poisoning and procedural complications
Post-polypectomy coagulation syndrome
|
0.00%
0/547 • 30 days
|
0.18%
1/551 • 30 days
|
|
Gastrointestinal disorders
Rectal absess
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illnesses and diseases
|
0.37%
2/547 • 30 days
|
0.54%
3/551 • 30 days
|
|
Gastrointestinal disorders
Unimportant bleed
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Renal and urinary disorders
Urinary tract infection
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
Other adverse events
| Measure |
Clip
n=547 participants at risk
A clip is been placed at the polypectomy site.
Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size
|
No Clip
n=551 participants at risk
A hemoclip is not placed at the site of the polypectomy.
NO hemoclip placement: No hemoclip placement (placebo / sham)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
2/547 • 30 days
|
0.18%
1/551 • 30 days
|
|
Injury, poisoning and procedural complications
Multiple falls
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/547 • 30 days
|
0.18%
1/551 • 30 days
|
|
Gastrointestinal disorders
Unimportant bleed
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
|
Gastrointestinal disorders
Rectal pain
|
0.18%
1/547 • 30 days
|
0.00%
0/551 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place