Randomized Clinical Trial on Pre-emptive Endoscopic Vacuum Therapy Versus Conventional Management for the Prevention of Anastomotic Leakage After Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of Participants with Anastomotic Leak within 30 days
研究概览
简要总结
Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.).
- •Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III.
- •Anastomosis to be performed in a single stage (meeting anastomotic criteria).
- •Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.
排除标准
- •Preexisting anastomotic leakage or severe intra-abdominal infection before surgery.
- •Complicated by severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, acute phase of cerebral infarction).
- •Severe liver or kidney dysfunction (liver function Child-Pugh class C, creatinine clearance <30 ml/min).
- •Coagulation disorders (platelets <50×10⁹/L, INR >1.5) or receiving anticoagulant therapy that cannot be adjusted.
- •History of abdominal radiotherapy or multiple abdominal surgeries leading to severe intra-abdominal adhesions.
- •Complicated by other malignant tumors and currently undergoing radiotherapy or chemotherapy.
- •Psychiatric illness or cognitive impairment preventing compliance with the study.
结局指标
主要结局
Number of Participants with Anastomotic Leak within 30 days
时间窗: 30 days
Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.
次要结局
- Number of Participants with Postoperative Complications within 30 days(30 days)