The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 11, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 4, 2014
November 1, 2014
9 months
January 11, 2014
November 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Complete resection rate of colorectal polyps
The complete resection rate of colorectal polyps based on the pathological examination.
2 weeks
Secondary Outcomes (1)
Postpolypectomy bleeding
2 weeks
Other Outcomes (1)
The procedure time
1 day
Study Arms (2)
Exclusive cold polypectomy snare
EXPERIMENTALAll 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.
regular polypectomy snare
ACTIVE COMPARATORAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with colorectal polyps up to 10 mm in diameter.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Showa Inan General Hospital
Komagane, Nagano, 399-4117, Japan
Related Publications (1)
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.
PMID: 25922251DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Digestive Disease Center
Study Record Dates
First Submitted
January 11, 2014
First Posted
January 14, 2014
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 4, 2014
Record last verified: 2014-11