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Completed

NCT Number: NCT02156193

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

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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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Incheon St. Mary's Hospital, The Catholic University of Korea

Incheon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic clip

Procedure

Prophylactic clipping

No prophylactic management

Procedure

No prophylaxis

Primary outcomes

  1. Postpolypectomy bleeding

    Time frame: 1 month

    Immediate and delayed postpolypectomy bleeding

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Large Pedunculated Colonic Polyps: a Randomized, Controlled Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2014
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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