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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colonic Neoplasms

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with colonic neoplasms

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ESD; Cohort of patients with giant colonic lesions resected by ESD, in which patients will be matched to group B
surgery; Cohort of patients who underwent colonic surgery for T1 or T2 or in situ colon cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): June 17, 2025
• Study Completion (Estimated): June 17, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: colonic neoplasms; endoscopy submucosal dissection; colonic surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 29BRC24.0088 - MORDIGO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No