Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm) - A Randomised Control Trail.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events. DESIGN : A Randomised interventional study. Sample size: 330
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Adult above 18 years
• polyp size greater than 5-10mm.
Locations
Other Locations
India
Krithi Krishna Koduri
RECRUITING
Hyderabad
Contact Information
Primary
Krithi Krishna Koduri, MD
drkrithivk@gmail.com
9870083545
Backup
Nitin Jagtap, MD
Docnits13@gmail.com
9182859523
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 330
Treatments
Active_comparator: cold snare endoscopic mucosal resection (C-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Sham_comparator: Hot snare endoscopic mucosal resection (H-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Related Therapeutic Areas
Sponsors
Leads: Asian Institute of Gastroenterology, India