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Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy (COLD)

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. Identifier: NCT00763425
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

Brief Summary:

The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.

Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: cold polypectomy Procedure: conventional polypectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1 Procedure: cold polypectomy
The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.
Other Name: cold snare polypectomy

Active Comparator: 2 Procedure: conventional polypectomy
The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.
Other Name: polypectomy

Primary Outcome Measures :
  1. Complete removal rate of colorectal polyps [ Time Frame: two weeks after each polypectomy ]

Secondary Outcome Measures :
  1. Complication rate [ Time Frame: two weeks after each polypectomy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Men or women between 20 and 100 years of age

Exclusion Criteria:

  • Exclusion criteria include age less than 20 years old
  • Pregnant, American Society of Anesthesiologists class III and IV
  • Overweight (body weight > 100 kg)
  • Allergic to the drugs used or its components (soybeans or eggs)
  • Poor bowel preparation or post-colorectal surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763425

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Showa Inan General hospital
Komagane, Nagano, Japan, 399-4191
Sponsors and Collaborators
Showa Inan General Hospital
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Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital Identifier: NCT00763425    
Other Study ID Numbers: 200888
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
colonic polyp
colorectal polyp
colorectal cancer prevention
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases