Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371898
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-15
Brief Title:
Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery a National Multicenter Study MORDIGO
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery a National Multicenter Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
MORDIGO
Brief Summary:
Propose a one-piece endoscopic resection such as endoscopic submucosal dissection ESD rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability This approach is all the more in the rectum even for giant lesions lesions over 8cm as rectal surgery is particularly morbid with particularly morbid with a functional impact that can impact whereas rectal ESD is less prone to complications fewer complications than in the colon Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions the question of colonic surgery in this indication this indication In order to compare the morbidity data of patients of giant lesions with those of colectomy a control group colectomy a surgical control group will be set up including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison T3 and T4 lesions with their own their own morbidity will be excluded
Detailed Description:
None
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