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

Colonic Neoplasms Clinical Trial

— MORDIGO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06371898
• Other study ID #: 29BRC24.0088 - MORDIGO
• Status: Active, not recruiting
• Start date: March 18, 2024
• Est. completion date: June 17, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 17, 2025
• Est. primary completion date: June 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms

Locations

Country	Name	City	State
France	Chu Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 days severe morbidity	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)	30 days
Secondary	morbidity of ESD group		30 days
Secondary	comparison of morbidity in both groups		30 days
Secondary	reintervention		30 days
Secondary	stomia		30 days
Secondary	length of hospital stay		30 days
Secondary	readmission		30 days
Secondary	mortality		30 days
Secondary	risk factors for morbidity		30 days