Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas
- Conditions
- Colorectal Polyp
- Interventions
- Procedure: Cold snare polypectomyProcedure: Hot snare polypectomy
- Registration Number
- NCT03859479
- Lead Sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Brief Summary
A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.
- Detailed Description
Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.
All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- Patients with non-pedunculated colorectal adenomas who had provided written informed consent
- known coagulopathy.
- polyposis of the alimentary tract.
- inflammatory bowel disease.
- malignant polyps.
- associated diseases in the stage of decompensation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cold snare polypectomy Cold snare polypectomy After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital Hot snare polypectomy Hot snare polypectomy After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital
- Primary Outcome Measures
Name Time Method R0 resection rate 14 days Complete resection rate 1 day
- Secondary Outcome Measures
Name Time Method Use of submucosal injection 1 day Complication rate 14 days The procedure time 1 day The immediate bleeding or immediate perforation rate after polypectomy 1 day Incidence of local recurrence 6 months Polyp retrieval rate 1 day
Trial Locations
- Locations (1)
State Scientific Centre of Coloproctology
🇷🇺Moscow, Russian Federation