NCT03699761招募中不适用
Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Grade III-IV complications
研究概览
简要总结
A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
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
- •Matching the diagnostic criteria of rectal adenocarcinoma
- •Laparoscopic or robotic radical surgery for rectal cancer
- •Preoperative TNM staging T1-3N0-2M0
- •No history of malignant tumors by preoperative examination
- •Middle and low rectal cancer
- •Tumor size of 4 cm or less
- •ASA 1-3 scores
- •Written informed consent by the patient
- •The patient is willing to randomize to any group
排除标准
- •Previous abdominal surgery
- •Past malignant tumor history
- •Preoperative examination suggests distant metastasis
- •Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
- •Emergency operation
- •Elimination criteria
- •The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
- •The anastomosis is located above the peritoneum reflex
- •Intraoperative conversion to laparotomy
- •Change the surgical method to perform Miles or Hartmann surgery
- •Postoperative pathologically confirmed non-adenocarcinoma
- •The patient asked to withdraw
结局指标
主要结局
Grade III-IV complications
时间窗: 30 days
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
次要结局
- Operation time(1 day)
- Treatment cost(30 days)
- LARS(12 months)
- Detection of other inflammation markers(7 days)
- Estimated blood loss(1 day)
- Detection of inflammation markers(7 days)
- Overall complication rate(30days)
- Readmission rate(30 days)
- Rate of reoperation(30 days)
- Hospital time(30 days)
- The rate of anastomotic leakage(30 days)
- Postoperative bleeding(7 days)
- Intestinal obstruction(30 days)
- Acute inflammatory Response(7 days)
研究者
Tang Bo
Principal Investigator
Southwest Hospital, China
研究点 (1)
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