Back to resultsThe Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
Primary Purpose
Diminutive Colorectal Polyp, Cold Snare Polypectomy, Polypectomy Snare
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)
Regular polypectomy snare (Snare Master, SD-210U-10)
Sponsored by
About this trial
This is an interventional treatment trial for Diminutive Colorectal Polyp
Eligibility Criteria
Inclusion Criteria:
- Patients with colorectal polyps up to 10 mm in diameter.
Exclusion Criteria:
- patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical resection.
Sites / Locations
- Showa Inan General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exclusive cold polypectomy snare
regular polypectomy snare
Arm Description
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using an exclusive cold polypectomy snare (Exacto cold snare). The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy.
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using a regular polypectomy snare. The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy.
Outcomes
Primary Outcome Measures
Complete resection rate of colorectal polyps
The complete resection rate of colorectal polyps based on the pathological examination.
Secondary Outcome Measures
Postpolypectomy bleeding
Postpolypectomy bleeding within two weeks after cold snare polypectomy
Full Information
NCT ID
NCT02036047
First Posted
January 11, 2014
Last Updated
November 2, 2014
Sponsor
Showa Inan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02036047
Brief Title
The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (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 use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diminutive Colorectal Polyp, Cold Snare Polypectomy, Polypectomy Snare, Complete Resection Rate, Postpolypectomy Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exclusive cold polypectomy snare
Arm Type
Experimental
Arm Description
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using an exclusive cold polypectomy snare (Exacto cold snare). The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy.
Arm Title
regular polypectomy snare
Arm Type
Active Comparator
Arm Description
All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using a regular polypectomy snare. The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy.
Intervention Type
Device
Intervention Name(s)
exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)
Intervention Type
Device
Intervention Name(s)
Regular polypectomy snare (Snare Master, SD-210U-10)
Primary Outcome Measure Information:
Title
Complete resection rate of colorectal polyps
Description
The complete resection rate of colorectal polyps based on the pathological examination.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Postpolypectomy bleeding
Description
Postpolypectomy bleeding within two weeks after cold snare polypectomy
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
The procedure time
Description
The procedure time spent for cold snare polypectomy
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with colorectal polyps up to 10 mm in diameter.
Exclusion Criteria:
patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical resection.
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25922251
Citation
Horiuchi A, Hosoi K, Kajiyama M, Tanaka N, Sano K, Graham DY. Prospective, randomized comparison of 2 methods of cold snare polypectomy for small colorectal polyps. Gastrointest Endosc. 2015 Oct;82(4):686-92. doi: 10.1016/j.gie.2015.02.012. Epub 2015 Apr 25.
Results Reference
derived
Learn more about this trial
The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
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