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Comparison of Prophylactic Clip and Detachable Snare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 1, 2011
Last Update Posted Date August 20, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
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). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01406379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Prophylactic Clip and Detachable Snare
Official Title  ICMJE Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonic Polyp
Intervention  ICMJE
  • Procedure: Prophylactic clip
    Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
  • Procedure: Detachable snare
    In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy
Study Arms  ICMJE
  • Experimental: Prophylactic clip
    Prophylactic clip
    Intervention: Procedure: Prophylactic clip
  • Active Comparator: Detachable snare
    Detachable snare
    Intervention: Procedure: Detachable snare
Publications * 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. Erratum in: Endoscopy. 2014 Dec;46(12):1123. Endoscopy. 2014 Sep;46(9):817.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2013)
203
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2011)
200
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01406379
Other Study ID Numbers  ICMJE Prophylatic clip
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeong-Seon Ji, The Catholic University of Korea
Study Sponsor  ICMJE The Catholic University of Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Catholic University of Korea
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP