Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colonic Neoplasms
- Sponsor
- University Hospital, Brest
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- 30 days severe morbidity
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
- •Patient affiliated to a social security scheme
- •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
- •patient affiliated to a social security scheme
Exclusion Criteria
- •- rectal lesion ;
- •patients under legal protection (guardianship, curatorship,
- •...) or deprived of liberty ;
- •refusal to participate.
Outcomes
Primary Outcomes
30 days severe morbidity
Time Frame: 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 Outcomes
- comparison of morbidity in both groups(30 days)
- morbidity of ESD group(30 days)
- risk factors for morbidity(30 days)
- stomia(30 days)
- length of hospital stay(30 days)
- readmission(30 days)
- reintervention(30 days)
- mortality(30 days)