Text Size

Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

This study is currently recruiting participants.
Verified June 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01625247
First received: June 12, 2012
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.


Condition Intervention Phase
Acute Cholecystitis
Empyema
 Procedure: Surgical drainage
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • frequency of postoperative complication occurrence [ Time Frame: whinin 1 week and 8 weeks postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 arm
Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
 Procedure: Surgical drainage
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.
Active Comparator: 2 arm
Patients under LC. Allocation to sham drain,
 Procedure: Surgical drainage
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute cholecystis
  • Laparoscopic cholecystectomy
  • KAROFSKY PERFORMANCE SCALE > 70
  • No history of major operation

Exclusion Criteria:

  • NYHA class > 3
  • Open cholecystectomy
  • No- compliance
  • Intraoperative injuries
  • Inadequate hemostasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625247

Contacts
Contact: Dong Sup Yoon, MD 82-2-2019-2444 yds1660@yuhs.ac

Locations
Korea, Republic of
Gangnam Severance hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Dong Sup Yoon, MD     82-2-2019-2444     yds1660@yuhs.ac    
Principal Investigator: Dong Sup Yoon, MD            
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01625247     History of Changes
Other Study ID Numbers: 3-2008-0140
Study First Received: June 12, 2012
Last Updated: June 20, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Empyema
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
 Digestive System Diseases
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013