Effects of Drainage in Laparoscopic Cholecystectomy

NCT ID: NCT02027402

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

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.

Conditions

Acute Cholecystitis; Empyema of Gallbladder; Abscess of Gallbladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Drain insertion

Laparoscopic cholecystectomy with drain insertion is performed in this arm.

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy with drain insertion

Intervention Type: PROCEDURE

In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space

no drain insertion

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laparoscopic cholecystectomy with drain insertion

In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incheon St.Mary's Hospital

OTHER

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taeho Hong

Assistant proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taeho Hong

Role: PRINCIPAL_INVESTIGATOR

SeoulSt.Mary's hospital

Locations

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, South Korea

Countries

South Korea

References

Kim EY, Lee SH, Lee JS, Yoon YC, Park SK, Choi HJ, Yoo DD, Hong TH. Is routine drain insertion after laparoscopic cholecystectomy for acute cholecystitis beneficial? A multicenter, prospective randomized controlled trial. J Hepatobiliary Pancreat Sci. 2015 Jul;22(7):551-7. doi: 10.1002/jhbp.244. Epub 2015 Apr 16.

Reference Type: DERIVED

PMID: 25881915 (View on PubMed)

Other Identifiers

seoul -S2

Identifier Type: -

Identifier Source: org_study_id