NCT02905968Unknown2 期
The Safety and Effect of Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer to Prevent Anastomotic Leak: Randomized Control Trial Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 520
- 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 effectiveness of transanual tube placement in low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.
详细描述
Transanual tube placement after anastomosis in 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
- •Age ≥ 18 and ≤ 75 years;
- •Primary tumor has undergone histologically confirmed rectal adenocarcinoma; 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).
- •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 2010 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/m
- •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
TTPLAR
Experimental
Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
干预措施: transanual tube placement (Device)
NORLAR
No Intervention
Tranditional low anterior resection without transanual tube placement or ileostomy.
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
- Time Frame: Reoperation rate after anastomotic leak(30 days post operatively)
研究者
研究点 (1)
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