Colorectal Polyp
Conditions
Keywords
Cold snare polypectomy, Hot snare polypectomy, Сolorectal polyps, Endoscopic treatment
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.
Interventions
PROCEDURECold 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
PROCEDUREHot 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
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | 14 days |
| Complete resection rate | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| The immediate bleeding or immediate perforation rate after polypectomy | 1 day |
| Complication rate | 14 days |
| The procedure time | 1 day |
| Polyp retrieval rate | 1 day |
| Use of submucosal injection | 1 day |
| Incidence of local recurrence | 6 months |
Countries
Russia
Outcome results
None listed