A Prospective Cohort Study of Robotic Transanal Total Mesentery Excision Versus Conventional Robotic Surgery for Rectal Cancer in Low Site
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 主要终点
- Positive rate of circumferential resection margin (CRM) of the specimens
研究概览
简要总结
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.
详细描述
Transanal total mesorectal excision (TaTME) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in rectal cancer surgery. However, the narrow angle and limited space of the operation restrict the wide spread of this technique. Da Vinci robotic system has achieved good results in rectal cancer surgery. Robotics may help to overcome technical difficulties in TaTME. The purpose of this study was to explore the availability of Da Vinci robotic-assisted transanal total mesorectal excision(R-TaTME) This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenocarcinoma of the rectum by biopsy
- •the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy
- •tumor diameter less than 4cm
- •baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
- •tolerable to surgery
- •be able to understand and willing to participate in this trial with signature
排除标准
- •history of malignant colorectal neoplasia
- •recent diagnosis with other malignancies
- •patients requiring emergency surgery such as obstruction，perforation and bleeding
- •tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer
- •preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis
- •participating in other clinical trails
- •History of pelvic radiation
- •BMI > 40
- •Large uterine fibroids
- •can not tolerate the surgery
- •history of serious mental illness
- •pregnancy or lactating women
- •preoperative uncontrolled infection
- •the researchers believe the patients should not enrolled in
研究组 & 干预措施
R-TME
Robotic total mesentery excision surgery for rectal cancer.
干预措施: R-TME (Procedure)
R-TaTME
Robotic transanal total mesentery excision surgery for rectal cancer.
干预措施: R-TaTME (Procedure)
结局指标
主要结局
Positive rate of circumferential resection margin (CRM) of the specimens
时间窗: 10 days after surgery
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.
次要结局
- The distance between lower tumor margin and the lower reaction margin(10 days after surgery)
- the rate of postoperative complications(30 days after surgery)
- disease free survival rate(3 years after surgery)
- postoperative hospital stay(3 years after surgery)
- The grade score of the specimens integrity(10 days after surgery)
- overall survival rate(3 years after surgery)
研究者
fan li
Prof.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University