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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prophylactic clip

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

Group Type EXPERIMENTAL

Prophylactic clip

Intervention Type PROCEDURE

Prophylactic clipping

No prophylactic management

Conventional snare polypectomy will be performed without any preventive management.

Group Type ACTIVE_COMPARATOR

No prophylactic management

Intervention Type PROCEDURE

No prophylaxis

Interventions

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Prophylactic clip

Prophylactic clipping

Intervention Type PROCEDURE

No prophylactic management

No prophylaxis

Intervention Type PROCEDURE

Eligibility Criteria

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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.