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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625247
First Posted: June 21, 2012
Last Update Posted: June 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

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

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01625247     History of Changes
Other Study ID Numbers: 3-2008-0140
First Submitted: June 12, 2012
First Posted: June 21, 2012
Last Update Posted: June 21, 2012
Last Verified: June 2012

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