Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180798
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-10-21
Brief Title:
Cold Snare Endoscopic Mucosal Resection C-EMR Versus Hot Snare Endoscopic Mucosal Resection H-EMR for Large Colorectal Polyps 10-20 mm
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
DESIGN A Randomised interventional study Sample size 330
Detailed Description:
This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation
In Both groups a mixture of saline and blue dye will be injected beneath the surface layerand then a snareis a ring shaped device used to cut polyp after surrounding it- like a rubber band will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit to control bleeding and to rapidly dissect soft tissue in surgery by EndoCut Q mode ensures safe and effective removal of large lesions in particular large polyps in Hot Endoscopic mucosal resection group
After polypectomy the surgical removal of a polyp the area is inspected for residual polyp presence of any type of tissue using NBI Narrow band imaging and if present will be CUT OFF
A Standard snare snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band is used to cut the polyps
In Both groups a mixture of saline and blue dye will be injected beneath the surface layerand then a snareis a ring shaped device used to cut polyp after surrounding it- like a rubber band will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit to control bleeding and to rapidly dissect soft tissue in surgery by EndoCut Q mode ensures safe and effective removal of large lesions in particular large polyps in Hot Endoscopic mucosal resection group
After polypectomy the surgical removal of a polyp the area is inspected for residual polyp presence of any type of tissue using NBI Narrow band imaging and if present will be CUT OFF
A Standard snare snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band is used to cut the polyps
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None