Clinical trial NCT06371898: Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO)
Official title: Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colonic Neoplasms
Keywords: endoscopy submucosal dissection
colonic neoplasms
colonic surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with colonic neoplasms

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.


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
* 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.

Primary outcomes:
measure: 30 days severe morbidity
timeFrame: 30 days
Secondary outcomes:
measure: morbidity of ESD group
timeFrame: 30 days
measure: comparison of morbidity in both groups
timeFrame: 30 days
measure: reintervention
timeFrame: 30 days
measure: stomia
timeFrame: 30 days
measure: length of hospital stay
timeFrame: 30 days
measure: readmission
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
measure: risk factors for morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References: