The Effect of Combined Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube Placement in Robotic Low Anterior Resection for Rectal Cancer to Prevent Anastomic Leak：A Prospective, Single-center, Randomized Control Trial Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Anastomotic leak rate
研究概览
简要总结
The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.
详细描述
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of low rectal cancer; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin)
- •Primary tumor has undergone histologically comfirmed rectal adenocarcinoma
- •Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2016 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system)
- •Performance status (ECOG) 0~1
- •Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
- •Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- •Written informed consent for participation in the trial.
排除标准
- •Body mass index (BMI) more than 30 kg/m2
- •Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine >2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history
- •History of accepting abdominal surgery
研究组 & 干预措施
PSTLAR
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
干预措施: Transanal tube placement (Device)
PSTLAR
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
干预措施: Left colic artery preservation (Procedure)
PSTLAR
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
干预措施: Anastomotic reinforcing sutures (Procedure)
PSTLAR
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
干预措施: Robotic surgery (Device)
NORLAR
Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement
干预措施: Robotic surgery (Device)
结局指标
主要结局
Anastomotic leak rate
时间窗: 30 days post operatively
Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.
次要结局
- Reoperation rate after anastomotic leak(30 days post operatively)