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

NCT ID: NCT06371898

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2025-06-17

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.

Conditions

Colonic Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

ESD

Cohort of patients with giant colonic lesions resected by ESD, in which patients will be matched to group B

No interventions assigned to this group

surgery

Cohort of patients who underwent colonic surgery for T1 or T2 or in situ colon cancer

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Group A :
• Patients from the FECCO cohort
• who have undergone ESDresection of a giant lesion, defined by a fresh specimen measuring more than 8cm long axis, of the colon
• Between September 2019 and 2022
• Major
• Patient affiliated to a social security scheme

Group B:

• Patients from the Registre des Tumeurs Digestives Registry (Brest University Hospital)
• Having undergone colectomy with lymph node dissection for intramucosal colonic adenocarcinoma, T1 or T2 colonic adenocarcinoma
• Between September 2019 and 2022
• Adults
• patient affiliated to a social security scheme

Exclusion Criteria

• - rectal lesion ;
• patients under legal protection (guardianship, curatorship,

...) or deprived of liberty ;

• refusal to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Brest

Brest, , France

Countries

France

Other Identifiers

29BRC24.0088 - MORDIGO

Identifier Type: -

Identifier Source: org_study_id