Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

This study is currently recruiting participants.
Verified March 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01548339
First received: March 5, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 5, 2012
March 5, 2012
February 2009
February 2015   (final data collection date for primary outcome measure)
  • Global morbidity [ Designated as safety issue: No ]
  • Postoperative complications [ Designated as safety issue: No ]
Same as current
No Changes Posted
Cost analysis [ Designated as safety issue: No ]
Same as current
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?

Regarding surgical treatment of acute cholecystitis, there is a dogma that the patients should be operated within 72 hours of evolution. However, retrospective studies showed that laparoscopic cholecystectomy even after 72 hours was safe. There are randomized controlled-trials that found no difference in term of complications when comparing early to delayed cholecystectomy after acute cholecystitis, but none distinguished patients in terms of onset of symptoms.

The purpose of this study is to compare the clinical outcomes and economical issues of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.

Not Provided
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.
 
Recruiting
466
Not Provided
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
No
Contact: Luca Di Mare, MD luca.di-mare@chuv.ch
Switzerland
 
NCT01548339
252/08 CHV
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
March 2012

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