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Comparison of Prophylactic Clip and Detachable Snare

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ClinicalTrials.gov Identifier: NCT01406379
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Jeong-Seon Ji, The Catholic University of Korea

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colonic Polyp Procedure: Prophylactic clip Procedure: Detachable snare Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study
Study Start Date : July 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prophylactic clip
Prophylactic clip
 Procedure: Prophylactic clip
Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
Active Comparator: Detachable snare
Detachable snare
 Procedure: Detachable snare
In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeong-Seon Ji, MD, PhD, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01406379    
Other Study ID Numbers: Prophylatic clip
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps