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Comparison of Prophylactic Clip and Detachable Snare

This study is not yet open for participant recruitment.
Verified June 2011 by The Catholic University of Korea
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01406379
First received: July 29, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Colonic Polyp
Clip
 Procedure: Application of hemoclip
Procedure: Application of detachable snare

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Colonic Polyps
U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Postpolypectomy bleeding [ Time Frame: 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). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylatic clip group Procedure: Application of hemoclip
Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
Active Comparator: detachable snare group Procedure: Application of detachable snare
In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jin Kim, MD, PhD, The Catholic University of Korea, School of Medicine
ClinicalTrials.gov Identifier: NCT01406379     History of Changes
Other Study ID Numbers: Prophylatic clip
Study First Received: July 29, 2011
Last Updated: July 29, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013