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

The Catholic University of Korea

Status: Completed

Conditions: Bleeding

Treatments: Procedure: No prophylactic management; Procedure: Prophylactic clip

Study type: Interventional

Funder types: Other

Identifiers

NCT02156193

Clip control

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Prophylactic clip

Experimental group

Description:

Before conventional snare polypectomy, hemoclips will be applied on the base of stalk.

Treatment:

Procedure: Prophylactic clip

No prophylactic management

Active Comparator group

Description:

Conventional snare polypectomy will be performed without any preventive management.

Treatment:

Procedure: No prophylactic management