Effects of Drainage in Laparoscopic Cholecystectomy

Seoul St. Mary's Hospital

Status: Completed

Conditions: Empyema of Gallbladder; Abscess of Gallbladder; Acute Cholecystitis

Treatments: Procedure: Laparoscopic cholecystectomy with drain insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT02027402

seoul -S2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

Drain insertion

Experimental group

Description:

Laparoscopic cholecystectomy with drain insertion is performed in this arm.

Treatment:

Procedure: Laparoscopic cholecystectomy with drain insertion

no drain insertion

No Intervention group

Description:

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