Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Number of Participants With Subhepatic Collection at Ultrasonographic Examination
研究概览
简要总结
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.
详细描述
After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •elective laparoscopic cholecystectomy
排除标准
- •acute cholecystitis, cholangitis, or pancreatitis
- •no contraindication for the laparoscopic
- •no other additional procedure
结局指标
主要结局
Number of Participants With Subhepatic Collection at Ultrasonographic Examination
时间窗: first postoperative day
An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.
次要结局
- Number of Participants With Postoperative Complications(1 month)
研究者
Erasmo Spaziani
MD; PhD
University of Roma La Sapienza