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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

March 5, 2012
December 29, 2015
February 2009
February 2015   (final data collection date for primary outcome measure)
Global morbidity [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]
  • Global morbidity [ Designated as safety issue: No ]
  • Postoperative complications [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01548339 on ClinicalTrials.gov Archive Site
  • 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 ]
Cost analysis [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Cholecystitis
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy
  • Active Comparator: Delayed
    Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
    Intervention: Procedure: Laparoscopic cholecystectomy
  • Experimental: Early
    Laparoscopic cholecystectomy performed directly after the initial diagnosis
    Intervention: Procedure: Laparoscopic cholecystectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
86
October 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • proven echographic cholecystitis

Exclusion Criteria:

  • pregnancy
  • immunosuppression
  • severe sepsis
  • perforated cholecystitis
  • peritonitis
  • cholangitis
  • acute pancreatitis
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01548339
252/08 CHV
No
Not Provided
Not Provided
Nicolas DEMARTINES, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
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
University of Lausanne Hospitals
December 2015

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