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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763425
First Posted: October 1, 2008
Last Update Posted: November 18, 2015
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.
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Akira Horiuchi, Showa Inan General Hospital:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00763425


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

Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00763425     History of Changes
Other Study ID Numbers: 200888
First Submitted: September 29, 2008
First Posted: October 1, 2008
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Akira Horiuchi, 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