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Active Not RecruitingNCT06371898

Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO)

Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
University Hospital, Brest · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2024-03-18
Primary completion
2025-06-17
Completion
2025-06-17
First posted
2024-04-17
Last updated
2024-04-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06371898. Inclusion in this directory is not an endorsement.