Comparison of Prophylactic Clip and Detachable Snare

Colonic Polyp Clinical Trial

Official title:

Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406379
• Other study ID #: Prophylatic clip
• Status: Completed
• Phase: N/A
• First received: July 29, 2011
• Last updated: August 18, 2013
• Start date: July 2010
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps

Intervention

Procedure:
• Prophylactic clip
Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
• Detachable snare
In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Yes