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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

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.

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Empyema of Gallbladder Abscess of Gallbladder Procedure: Laparoscopic cholecystectomy with drain insertion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial
Study Start Date : November 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Complication [ Time Frame: 2 weeks ]
    complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.


Secondary Outcome Measures :
  1. Operative Time [ Time Frame: 1day ]
  2. Postoperative Hospital Stay [ Time Frame: 2weeks ]
  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027402


Locations
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Korea, Republic of
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, Korea, Republic of, 137-701
Sponsors and Collaborators
Seoul St. Mary's Hospital
Incheon St.Mary's Hospital
Investigators
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Principal Investigator: Taeho Hong SeoulSt.Mary's hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taeho Hong, Assistant proffesor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02027402    
Other Study ID Numbers: seoul -S2
First Posted: January 6, 2014    Key Record Dates
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Empyema
Cholecystitis
Cholecystitis, Acute
Suppuration
Infection
Inflammation
Pathologic Processes
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases