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

June 12, 2012
June 20, 2012
June 2009
December 2012   (final data collection date for primary outcome measure)
frequency of postoperative complication occurrence [ Time Frame: whinin 1 week and 8 weeks postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01625247 on ClinicalTrials.gov Archive Site
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Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
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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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Cholecystitis
  • Empyema
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.
  • Experimental: 1 arm
    Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
    Intervention: Procedure: Surgical drainage
  • Active Comparator: 2 arm
    Patients under LC. Allocation to sham drain,
    Intervention: Procedure: Surgical drainage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
162
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Dong Sup Yoon, MD 82-2-2019-2444 yds1660@yuhs.ac
Korea, Republic of
 
NCT01625247
3-2008-0140
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
June 2012

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