Elective Colonoscopy, Polypectomy, Post-polypectomy Bleeding
Conditions
Keywords
hemoclip, colonoscopy, post-polypectomy bleed
Brief summary
A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.
Interventions
DEVICEHemoclip Placement
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
DEVICENO hemoclip placement
No hemoclip placement (placebo / sham)
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting for elective colonoscopy
Exclusion criteria
* Patients in which polypectomy can not be performed safely
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Delayed Post Polypectomy Bleeding | 30 days | rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
Must have polyp 1cm in size removed during colonoscopy
Participants by arm
| Arm | Count |
|---|---|
| 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 | 530 |
| No Clip A hemoclip is not placed at the site of the polypectomy.
NO hemoclip placement: No hemoclip placement (placebo / sham) | 520 |
| Total | 1,050 |
Baseline characteristics
| Characteristic | Total | Clip | No Clip |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 553 Participants | 279 Participants | 274 Participants |
| Age, Categorical Between 18 and 65 years | 497 Participants | 251 Participants | 246 Participants |
| Age, Continuous | 64.3 years STANDARD_DEVIATION 8.2 | 64.5 years STANDARD_DEVIATION 7.9 | 64.0 years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized black | 227 Participants | 117 Participants | 110 Participants |
| Race/Ethnicity, Customized hispanic | 73 Participants | 42 Participants | 31 Participants |
| Race/Ethnicity, Customized other | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized white | 745 Participants | 370 Participants | 375 Participants |
| Region of Enrollment United States | 1050 Participants | 530 Participants | 520 Participants |
| Sex: Female, Male Female | 35 Participants | 14 Participants | 21 Participants |
| Sex: Female, Male Male | 1015 Participants | 516 Participants | 499 Participants |
| smoking | 387 Participants | 197 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 547 | 1 / 551 |
| other Total, other adverse events | 5 / 547 | 2 / 551 |
| serious Total, serious adverse events | 25 / 547 | 21 / 551 |
Outcome results
Primary
Number of Patients With Delayed Post Polypectomy Bleeding
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clip | Number of Patients With Delayed Post Polypectomy Bleeding | 12 Participants |
| No Clip | Number of Patients With Delayed Post Polypectomy Bleeding | 15 Participants |