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

November 17, 2015 updated by: Akira Horiuchi, Showa Inan General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4191
        • Showa Inan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete removal rate of colorectal polyps
Time Frame: two weeks after each polypectomy
two weeks after each polypectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: two weeks after each polypectomy
two weeks after each polypectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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