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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
ClinicalTrials.gov Identifier:
NCT00763425
First received: September 29, 2008
Last updated: August 21, 2011
Last verified: September 2008
History of Changes
  Purpose

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 Intervention
Colorectal Cancer
 Procedure: cold polypectomy
Procedure: conventional polypectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • Complete removal rate of colorectal polyps [ Time Frame: two weeks after each polypectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: two weeks after each polypectomy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763425

Locations
Japan
Showa Inan General hospital
Komagane, Nagano, Japan, 399-4191
Sponsors and Collaborators
Showa Inan General Hospital
  More Information

No publications provided

Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00763425     History of Changes
Other Study ID Numbers: 200888
Study First Received: September 29, 2008
Last Updated: August 21, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa Inan General Hospital:
polypectomy
colonic polyp
colorectal polyp
colorectal cancer prevention

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 17, 2013