Back to resultsProspective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy (COLD)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
cold polypectomy
conventional polypectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring polypectomy, colonic polyp, colorectal polyp, colorectal cancer prevention
Eligibility 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.
Sites / Locations
- Showa Inan General hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Complete removal rate of colorectal polyps
Secondary Outcome Measures
Complication rate
Full Information
NCT ID
NCT00763425
First Posted
September 29, 2008
Last Updated
November 17, 2015
Sponsor
Showa Inan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00763425
Brief Title
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy
Acronym
COLD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
polypectomy, colonic polyp, colorectal polyp, colorectal cancer prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
cold polypectomy
Other Intervention Name(s)
cold snare polypectomy
Intervention Description
The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.
Intervention Type
Procedure
Intervention Name(s)
conventional polypectomy
Other Intervention Name(s)
polypectomy
Intervention Description
The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.
Primary Outcome Measure Information:
Title
Complete removal rate of colorectal polyps
Time Frame
two weeks after each polypectomy
Secondary Outcome Measure Information:
Title
Complication rate
Time Frame
two weeks after each polypectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Showa Inan General hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4191
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy
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