Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- postoperative morbidity
研究概览
简要总结
This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.
详细描述
Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently.
The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients in need of emergency colon resection
排除标准
- •age < 18 year
- •trauma patients
- •reoperations
- •acute pancreatitis
研究组 & 干预措施
Laparoscopic operation
Laparoscopic emergency colon resection
干预措施: Laparoscopic operation (Procedure)
Open operation
Open emergency colon resection
干预措施: Open operation (Procedure)
结局指标
主要结局
postoperative morbidity
时间窗: 30 days
Postoperative morbidity evaluated by Clavien-Dindo classification
次要结局
- Surgical site infections(30 days)
- Long-term Survival(5 years)