跳至主要内容
临床试验/NCT02027402
NCT02027402已完成不适用

To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
1
主要终点
Complication

研究概览

简要总结

During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.

详细描述

Drain has been widely used in many abdominal surgeries for therapeutic purposes such as the removal of infected debris or abscess, and supporting the healing of leakage or fistula. Although the usability of therapeutic drain is commonly accepted, the efficacy of prophylactic drain still has been debated. Most surgeons have inserted prophylactic drain with expectations that the drain would be helpful for early detection of postoperative bleeding or leakage, and also prevention of intra-abdominal abscess through removing debris or curd. However, there are only few evidence-based studies for the actual effectiveness of prophylactic drain and the objections against the routine use of drain have been raised.

Most surgeons have placed the drain after cholecystectomy with expectations that it could help to detect postoperative bleeding or bile leakage and prevent intra-abdominal infection. However, there is a lack of evidence regarding the role of drain in laparoscopic cholecystectomy for acutely inflamed gallbladder and surgeons have placed the drain based on their experiences and beliefs, not on evidence-based guidelines. In the previous retrospective study, [4] we described that the routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder has no advantage to detect bile leak or bleeding and it was no helpful to prevent the postoperative morbidities such as intra-abdominal abscess or wound infection. The aim of present multicenter trial is to assess the value of routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder in a large, randomized controlled prospective study.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •acutely inflamed gallbladder

排除标准

  • •chronic cholecystitis
  • •gallbladder polyp or gallbladder cancer
  • •the patient who underwent reduced port surgery
  • •the patient who underwent common bile duct exploration during the operation
  • •the patient who underwent concurrent operation
  • •the patient who had past history of upper abdominal surgery
  • •the patient who had a immunodeficiency state
  • •the case which had a suspicion of delayed bile leakage
  • •the case which had a incomplete cystic duct ligation
  • •the patient who underwent open conversion surgery during the operation
  • •the patient who had a high risk of bleeding

研究组 & 干预措施

Drain insertion

Experimental

Laparoscopic cholecystectomy with drain insertion is performed in this arm.

干预措施: Laparoscopic cholecystectomy with drain insertion (Procedure)

no drain insertion

No Intervention

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain

结局指标

主要结局

Complication

时间窗: 2 weeks

complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.

次要结局

  • Operative Time(1day)
  • Postoperative Hospital Stay(2weeks)
  • Postoperative Pain Score(6hr after operation - 24hr after operation - 48hr after operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taeho Hong

Assistant proffesor

Seoul St. Mary's Hospital

研究点 (1)

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