Effects of Drainage in Laparoscopic Cholecystectomy
Primary Purpose
Acute Cholecystitis, Empyema of Gallbladder, Abscess of Gallbladder
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy with drain insertion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis
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
Sites / Locations
- Department of HBP Surgery, Seoul St. Mary's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Drain insertion
no drain insertion
Arm Description
Laparoscopic cholecystectomy with drain insertion is performed in this arm.
In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Outcomes
Primary Outcome Measures
Complication
complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
Secondary Outcome Measures
Operative Time
Postoperative Hospital Stay
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.
Full Information
NCT ID
NCT02027402
First Posted
December 30, 2013
Last Updated
November 30, 2014
Sponsor
Seoul St. Mary's Hospital
Collaborators
Incheon St.Mary's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02027402
Brief Title
Effects of Drainage in Laparoscopic Cholecystectomy
Official Title
To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
Incheon St.Mary's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis, Empyema of Gallbladder, Abscess of Gallbladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drain insertion
Arm Type
Experimental
Arm Description
Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Arm Title
no drain insertion
Arm Type
No Intervention
Arm Description
In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy with drain insertion
Intervention Description
In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space
Primary Outcome Measure Information:
Title
Complication
Description
complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Operative Time
Time Frame
1day
Title
Postoperative Hospital Stay
Time Frame
2weeks
Title
Postoperative Pain Score
Description
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.
Time Frame
6hr after operation - 24hr after operation - 48hr after operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taeho Hong
Organizational Affiliation
SeoulSt.Mary's hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of HBP Surgery, Seoul St. Mary's hospital
City
Seoul
State/Province
Seocho-gu, Banopo-dong
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25881915
Citation
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.
Results Reference
derived
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Effects of Drainage in Laparoscopic Cholecystectomy
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