Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Yonsei University.
Recruitment status was  Recruiting
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
  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

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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Acalculous Cholecystitis
Cholecystitis
Cholecystitis, Acute
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on November 23, 2014