Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Puncture drainage Puncture drainage
研究概览
简要总结
Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
详细描述
The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Compare complications as below betwwen drainage and no drainage groups.
- VAS
- Nause and vomiting
- infection
- bleeding
- bile leakage
- puncture drainage
- readmission
- reoperation
- hospital stay
- hospital expense
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:18-75 years old
- •indicated and planed to receive laparoscopic cholecystectomy
排除标准
- •cirrohosis Child Grading B and C
- •upper abdominal surgery history
- •adjustment of surgical name intraoperative
研究组 & 干预措施
drainage
Placement of subhepatic drainage tube for laparoscopic cholecytetomy
干预措施: drainage tube (Procedure)
no drainage
no placement of subhepatic drainage tube for laparoscopic cholecytetomy
结局指标
主要结局
Puncture drainage Puncture drainage
时间窗: day 1 to one month post LC operation
the percentage of puncture drainage Puncture drainage Puncture drainage
readmission
时间窗: day 1 to one month post LC operation
the percentage of readmission
bleeding Bile leakage
时间窗: day 1 to one month post LC operation
the morbidity of bleeding the morbidity of bile leakage
bile leakage
时间窗: day 1 to one month post LC operation
the morbidity of bile leakage
reoperation Reoperation
时间窗: day 1 to one month post LC operation
the percentage of reoperation
次要结局
- Hospitalization expenses(day 1 to discharge post LC operation)
- VAS score(day 1 to discharge post LC operation)
- infection(day 1 to discharge post LC operation)
- hospital stay(day 1 to discharge post LC operation)
- Nausea and vomiting(day 1 to discharge post LC operation)