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

Active, not recruiting

• Conditions: Colonic Neoplasms

• Registration Number: NCT06371898
• Lead Sponsor: University Hospital, Brest

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

Not available

Study Timeline

• Study Start: 2024-03-18
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-06-17
• Study Completion: 2025-06-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30 days severe morbidity	30 days	Comparison of severe morbidity (Clavien dindo ≥ IIIb) at 30 days of patients who underwent DSM for giant colonic lesion (group A) to that of patients who underwent surgery surgery equivalent to that which would be performed for such a lesion (group B)

Secondary Outcome Measures

Name	Time	Method
comparison of morbidity in both groups	30 days
stomia	30 days
morbidity of ESD group	30 days
risk factors for morbidity	30 days
length of hospital stay	30 days
readmission	30 days
reintervention	30 days
mortality	30 days

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France