Comparison of Prophylactic Clip and Detachable Snare
Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study
1 other identifier
interventional
203
0 countries
N/A
Brief Summary
Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 20, 2013
August 1, 2013
2.5 years
July 29, 2011
August 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Postpolypectomy bleeding
Immediate (bleeding occurring immediately after polypectomy and lasting for 30 s or more) and delayed bleeding complications were assessed. Delayed bleeding was subdivide into early (<24 h) and late (>24 h-30 days).
Study Arms (2)
Prophylactic clip
EXPERIMENTALProphylactic clip
Detachable snare
ACTIVE COMPARATORDetachable snare
Interventions
Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy
Eligibility Criteria
You may qualify if:
- Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.
You may not qualify if:
- bleeding tendency
- poor preparation
- sessile polyp
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15.
PMID: 24830400DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
July 29, 2011
First Posted
August 1, 2011
Study Start
July 1, 2010
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
August 20, 2013
Record last verified: 2013-08