A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
研究概览
简要总结
Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Based on the outcomes, the research doctors believe that this investigational surgery may be as safe and effective as standard laparoscopic or open surgery performed to remove rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions. In this research study, the investigators are looking to see if this investigational procedure is a safe and effective approach to remove rectal cancer of the mid and lower rectum.
详细描述
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. At the end of the procedure, the rectum will be removed though the anus, 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
- 18 Years 至 —（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 standard open or laparoscopic low anterior resection with 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 4-12 cm from the anal verge
- •ECOG performance status 2 or less
排除标准
- •Metastasis
- •Obstructing rectal cancer
- •Synchronous colon cancer
- •T3 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
- •Prior pelvic surgery or multiple abdominal procedures
- •BMI > 30
- •Large uterine fibroids
- •Uncontrolled intercurrent illness
- •Other malignancies diagnosed within the previous year, except basal cell cancer
研究组 & 干预措施
Transanal endoscopic surgery
Laparoscopy-assisted transanal endoscopic rectosigmoid resection
干预措施: Transanal endoscopic surgery (Procedure)
结局指标
主要结局
Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
时间窗: 1-5 years
次要结局
- Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection(1-5 years)
- Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.(1-5 years)
- Incidence of long-term complications(1-5 years)
研究者
Patricia Sylla
Assistant Professor of Surgery
Massachusetts General Hospital