Effects of Drainage in Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Cholecystitis; Empyema of Gallbladder; Abscess of Gallbladder
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy with drain insertion

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seocho-gu, Banopo-dong
    • Seoul, Seocho-gu, Banopo-dong, Korea, Republic of, 137-701
      • Department of HBP Surgery, Seoul St. Mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drain insertion; Laparoscopic cholecystectomy with drain insertion is performed in this arm.	Procedure: 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
No Intervention: no drain insertion; In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time		1day
Postoperative Hospital Stay		2weeks
Postoperative Pain Score	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.	6hr after operation - 24hr after operation - 48hr after operation

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: Incheon St.Mary's Hospital
• Investigators: Principal Investigator: Taeho Hong, SeoulSt.Mary's hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: November 30, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Suppuration; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Cholecystitis, Acute; Empyema
• Other Study ID Numbers: seoul -S2