A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
研究概览
简要总结
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
详细描述
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven adenocarcinoma of the rectum
- •Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma
- •Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
- •Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
- •Rectal cancer located 3-10 cm from the anal verge
排除标准
- •Metastasis
- •Obstructing rectal cancer
- •Synchronous colon cancer
- •T4 rectal cancer not treated preoperatively with full-course chemoradiation
- •Pregnant or breast-feeding
- •Receiving any other study agents
- •Fecal incontinence
- •History of prior colorectal cancer
- •History of inflammatory bowel disease
- •History of pelvic radiation
- •BMI > 40
- •Large uterine fibroids
- •Uncontrolled intercurrent illness
结局指标
主要结局
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
时间窗: 1-6 years
Lymph nodes number; rate of positive circumferential resection margin(CRM);
次要结局
- Incidence of long-term complications(1-6 years)
- Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.(1-6 years)
- Incidence of 30-day perioperative complications including intraoperative, and postoperative complications(0-30 days)
研究者
Weidong Tong
Dr
Third Military Medical University