Effects of Drainage in Laparoscopic Cholecystectomy

Acute Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027402
• Other study ID #: seoul -S2
• Status: Completed
• Phase: N/A
• First received: December 30, 2013
• Last updated: November 30, 2014
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess of Gallbladder
• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Empyema of Gallbladder

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of HBP Surgery, Seoul St. Mary's hospital	Seoul	Seocho-gu, Banopo-dong

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication	complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.	2 weeks	Yes
Secondary	Operative Time		1day	No
Secondary	Postoperative Hospital Stay		2weeks	No
Secondary	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	No