NCT05191602Unknown不适用
A Prospective and Analytical Study on the Detection of Early Anastomotic Leakage With Abdominal Drainage Fluid After Colorectal Cancer Surgery
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- leakage
研究概览
简要总结
A prospective and analytical study on the detection of early anastomotic leakage by abdominal drainage fluid after colorectal cancer surgery. pay attention to indicators including bilirubin
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Preoperative pathologically confirmed colorectal adenocarcinoma; 2) Patients undergoing minimally invasive (robot or laparoscopic) tumor resection + bowel anastomosis; 3) Age: 18 to 80 years old; 4) Preoperative TNM staging (whole abdomen) Enhanced CT or MRI, laparoscopic exploration): cT1-3bN0-2M0; 5) Preoperative ASA score: ≤Ⅲ; 6) No history of malignant tumors and no other malignant tumors by preoperative examination; 7) Not accepted before surgery Deterministic treatment, such as radiotherapy, chemotherapy or immunotherapy; 8) No pre-existing ascites was found before and during the operation; 9) Informed consent signed by the patient or his agent
- •Performance status (ECOG) 0~1
排除标准
- •Patients with obstructive jaundice or other congenital disorders of bile acid synthesis and metabolism; 2) Severe abdominal cavity infection and other infections; 3) A large amount of abdominal effusion was found before and during the operation; 4) Tumor was confirmed during the operation For T4b or intraoperative detection of other tumors, joint resection or distant metastasis is required; 5) Intraoperative conversion to laparotomy; 6) Intraoperative change of surgical method to perform Miles or Hartmann surgery; 7) Intraoperative and postoperative abdominal cavity Hyperthermic perfusion chemotherapy.
结局指标
主要结局
leakage
时间窗: 10days
次要结局
未报告次要终点
研究者
Li Chuan
Secretary of General Surgery
Southwest Hospital, China
研究点 (1)
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