None listed
Conditions
Brief summary
This study aims to assess whether the technique of snare tip soft coagulation (STSC) during polypectomy (removal of colon polyps) improves safety and reduces polyp recurrence. Who is it for? You may be eligible for this study if you are aged 18 years or above, and will undergo elective colonoscopy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. One group will be treated with STSC therapy following removal of their colonic polyp. The other group will be treated with standard of care during their removal of colonic polyps removed, without any additional procedures. After treatment, there will be 30-day monitoring of adverse events via a questionnaire. Polyp recurrence will be assessed at 6 months with a follow up colonoscopy. It is hoped that this research will reveal if the STSC technique is safe and effective in reducing polyp rates, thus improving patient outcomes and reducing risk of colon cancer.
Interventions
We are assessing whether additional snare tip soft coagulation (STSC) therapy applied to the resection margins of a defect following piecemeal removal of a large colonic polyp without electrocautery will reduce the risk of polyp recurrence. The safety profile of this intervention will also be assessed (although it has been found to be safe in other large multicentre studies).
STSC will be performed using the wire tip of a polypectomy snare. The tip is positioned 1-2mm beyond the end of the sna
We are assessing whether additional snare tip soft coagulation (STSC) therapy applied to the resection margins of a defect following piecemeal removal of a large colonic polyp without electrocautery will reduce the risk of polyp recurrence. The safety profile of this intervention will also be assessed (although it has been found to be safe in other large multicentre studies). STSC will be performed using the wire tip of a polypectomy snare. The tip is positioned 1-2mm beyond the end of the snare sheath and thermal ablation is applied to the edges of the polypectomy defect margins using this tip with the assistance of a microprocessor-controlled generator (SOFT COAG mode, 80W Effect 4, ERBE Electromedizin, Tubingen, Germany). The aim will be to create a 2mm circumferential rim of completely ablated tissue around the defect. This typically requires up to 5 minutes of additional procedure time and will be delivered to patients streamlined to the "intervention" arm of the study. Photodocumentation will be required following STSC. This will be performed by gastroenterologists who have experience in both resection of large polyps and application of STSC.
Sponsors
QEII Jubilee Hospital Gastroenterology Department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over 18 years of age who present for an elective colonoscopy will be invited to participate in this study. Subsequently, patients in which an eligible polyp is found and removed will be included in the data collection. An eligible polyp is an adenomatous appearing polyp 15mm or greater in size with a flat or sessile morphology (Paris 0-Is or 0-IIa) and NICE 2 surface where cold EMR is performed for removal.
Exclusion criteria
Patients with active inflammatory bowel disease Patients with implanted permanent pacemakers, implanted cardiac defibrillators or spinal cord stimulators
Outcome results
None listed