Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 30 days severe morbidity
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- rectal lesion ;
- •patients under legal protection (guardianship, curatorship,
- •...) or deprived of liberty ;
- •refusal to participate.
结局指标
主要结局
30 days severe morbidity
时间窗: 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)
次要结局
- 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)