A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Total Mesorectal Excision(TME) quality
研究概览
简要总结
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
详细描述
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 20-80 years
- •biopsy-proven adenocarcinoma of the rectum
- •clinical staging, (T1 or T2 or T3) with N0M0
- •Rectal cancer located 4-12 cm from the anal verge
- •ECOG performance status 2 or less
排除标准
- •Synchronous colon cancer or other malignancy
- •Obstructing rectal cancer
- •Pregnant or breast-feeding
- •Receiving any other study agents
- •Fecal incontinence
- •History of prior colorectal cancer or inflammatory bowel disease
- •BMI > 30
- •T3 rectal cancer not treated preoperatively with full-course chemoradiation
结局指标
主要结局
Total Mesorectal Excision(TME) quality
时间窗: 1-5 years
The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
次要结局
- 30-day postoperative complications, No. of harvested LN(1-5 years)
研究者
Jae Hwan Oh
Head of Center for Colorectal Cancer, National Cancer Center
National Cancer Center, Korea