Effects of Drainage in Laparoscopic Cholecystectomy

Not Applicable

Completed

Conditions: Acute Cholecystitis
Empyema of Gallbladder
Abscess of Gallbladder

Interventions: Procedure: Laparoscopic cholecystectomy with drain insertion

Registration Number: NCT02027402

Lead Sponsor: Seoul St. Mary's Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 198

Inclusion Criteria

acutely inflamed gallbladder

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain insertion	Laparoscopic cholecystectomy with drain insertion	Laparoscopic cholecystectomy with drain insertion is performed in this arm.

Primary Outcome Measures

Name	Time	Method
Complication	2 weeks	complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.

Secondary Outcome Measures

Name	Time	Method
Operative Time	1day
Postoperative Hospital Stay	2weeks
Postoperative Pain Score	6hr after operation - 24hr after operation - 48hr after operation	Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.