Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps

Not Applicable

Completed

• Conditions: Bleeding
• Interventions: Procedure: Prophylactic clip; Procedure: No prophylactic management

• Registration Number: NCT02156193
• Lead Sponsor: The Catholic University of Korea

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. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.

Detailed Description

Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base of the stalk, followed by conventional snare polypectomy. In conventional group, conventional snare polypectomy was done without any preventive management. Immediate and delayed bleeding complications were assessed.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• 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.

Exclusion Criteria

• bleeding tendency, poor preparation, sessile polyp

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic clip	Prophylactic clip	Before conventional snare polypectomy, hemoclips will be applied on the base of stalk.
No prophylactic management	No prophylactic management	Conventional snare polypectomy will be performed without any preventive management.

Primary Outcome Measures

Name	Time	Method
Postpolypectomy bleeding	1 month	Immediate and delayed postpolypectomy bleeding

Trial Locations

Locations (1)

Incheon St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Incheon, Korea, Republic of