NCT01406379

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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

2.5 years

First QC Date

July 29, 2011

Last Update Submit

August 18, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (2)

Prophylactic clip

EXPERIMENTAL

Prophylactic clip

Procedure: Prophylactic clip

Detachable snare

ACTIVE COMPARATOR

Detachable snare

Procedure: Detachable snare

Interventions

Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group

Prophylactic clip

In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy

Detachable snare

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • bleeding tendency
  • poor preparation
  • sessile polyp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15.

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 1, 2011

Study Start

July 1, 2010

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

August 20, 2013

Record last verified: 2013-08