Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The incidence of postoperative anastomotic leakage
研究概览
简要总结
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
详细描述
TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision. And the surgery would performed by two-team approach. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with 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
- Single (Outcomes Assessor)
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
- •Pathological biopsy confirmed adenocarcinoma of the rectum.
- •Preoperative assessment of tolerance to surgery without major organ dysfunction.
- •Patients must be able to understand and voluntarily sign written informed consent.
- •The surgical method is robotic assisted transanal total mesorectal excision
- •Distance of the edge of the tumour within 8 cm
排除标准
- •The patient cannot tolerate the operation.
- •Refusal to sign informed consent.
- •Patients with distant metastasis of rectal cancer.
- •The surgical method was changed to miles or Hartman;
- •Unable to complete the follow - up
结局指标
主要结局
The incidence of postoperative anastomotic leakage
时间窗: Within 30 days after surgery
The incidence of postoperative anastomotic leakage within 30 days after surgery
The distant metastasis rates of rectal cancer
时间窗: Five years after surgery
The incidence of distant metastasis rectal cancer within two years after surgery
The local recurrence rates of rectal cancer
时间窗: Two years after surgery
The incidence of local recurrence rectal cancer within two years after surgery
The five-year survival rates
时间窗: Five years after surgery
The 5-year survival rates of rectal cancer
次要结局
未报告次要终点
研究者
Weidong Tong
Professor
Third Military Medical University