Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas

Not Applicable

• Conditions: Colorectal Polyp

• 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.

Study Timeline

• Study Start: 2019-01-20
• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Status Verified: 2019-03
• Study First Posted: 2019-03-01
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients with non-pedunculated colorectal adenomas who had provided written informed consent

Exclusion Criteria

• 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

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
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
Complication rate	14 days

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation