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

NCT06371898 | Active Not Recruiting

• 1 other identifier: 29BRC24.0088 - MORDIGO
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

endoscopy submucosal dissection; colonic neoplasms; colonic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• morbidity of ESD group

  30 days

• comparison of morbidity in both groups

  30 days

• reintervention

  30 days

• stomia

  30 days

• length of hospital stay

  30 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with colonic neoplasms

You may qualify if:

• 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

You may not qualify if:

• \- rectal lesion ;
• patients under legal protection (guardianship, curatorship,
• ) or deprived of liberty ;
• refusal to participate.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: March 18, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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

Locations

FR (1)