Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01548339
First received: March 5, 2012
Last updated: December 29, 2015
Last verified: December 2015
  Purpose
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.

Condition Intervention
Acute Cholecystitis
Procedure: Laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Global morbidity [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: February 2009
Study Completion Date: October 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delayed
Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy
Experimental: Early
Laparoscopic cholecystectomy performed directly after the initial diagnosis
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy

Detailed Description:
In acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. However, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. Moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. The aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proven echographic cholecystitis

Exclusion Criteria:

  • pregnancy
  • immunosuppression
  • severe sepsis
  • perforated cholecystitis
  • peritonitis
  • cholangitis
  • acute pancreatitis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01548339

Locations
Switzerland
University of Lausanne Hospitals
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Chair: Nicolas Demartines, MD University of Lausanne Hospitals
Study Director: Nermin Halkic, MD University of Lausanne Hospitals
Principal Investigator: Luca Di Mare, MD University of Lausanne Hospitals
  More Information

Responsible Party: Nicolas DEMARTINES, Chairman of the Department of Surgery, Professor of Surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01548339     History of Changes
Other Study ID Numbers: 252/08 CHV 
Study First Received: March 5, 2012
Last Updated: December 29, 2015
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 25, 2016