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Effects of Drainage in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02027402
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Incheon St.Mary's Hospital
Information provided by (Responsible Party):
Taeho Hong, Seoul St. Mary's Hospital

Tracking Information
First Submitted Date  ICMJE December 30, 2013
First Posted Date  ICMJE January 6, 2014
Results First Submitted Date  ICMJE November 23, 2014
Results First Posted Date  ICMJE December 3, 2014
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2014)
Complication [ Time Frame: 2 weeks ]
complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
Complication [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2014)
  • Operative Time [ Time Frame: 1day ]
  • Postoperative Hospital Stay [ Time Frame: 2weeks ]
  • Postoperative Pain Score [ Time Frame: 6hr after operation - 24hr after operation - 48hr after operation ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • Operative Time [ Time Frame: 1day ]
  • Postoperative Hospital Stay [ Time Frame: 1week ]
  • Postoperative Pain Score [ Time Frame: 1week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Drainage in Laparoscopic Cholecystectomy
Official Title  ICMJE To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Cholecystitis
  • Empyema of Gallbladder
  • Abscess of Gallbladder
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Drain insertion
    Laparoscopic cholecystectomy with drain insertion is performed in this arm.
    Intervention: Procedure: Laparoscopic cholecystectomy with drain insertion
  • No Intervention: no drain insertion
    In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2014)
198
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02027402
Other Study ID Numbers  ICMJE seoul -S2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taeho Hong, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Seoul St. Mary's Hospital
Collaborators  ICMJE Incheon St.Mary's Hospital
Investigators  ICMJE
Principal Investigator: Taeho Hong SeoulSt.Mary's hospital
PRS Account Seoul St. Mary's Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP