Randomized Controlled Trial of Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- En-block resesction rate
研究概览
简要总结
Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
- •Have signed approved informed consent form for the study
- •preoperative stage uT0 and/or uT1, mrT0 and/or mrT1
排除标准
- •non-epithelial tumors
- •tumors </= 3 cm in size
- •recurrent tumors
- •suspicion of lymph node metastasis (N + disease)
- •preoperative stage uT2 and/or mrT2
- •mucous or low-grade adenocarcinoma
- •preoperative stage rM1 and/or uM1
结局指标
主要结局
En-block resesction rate
时间窗: 14 day
R0 resection rate
时间窗: 14 day
次要结局
- Incidence of locoregional recurrence(12 months)
- Morbidity defined by the Clavien-Dindo classification(30 day)
研究者
Rybakov Evgeny, MD
Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
State Scientific Centre of Coloproctology, Russian Federation