Brief Title
Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
Official Title
Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
Brief Summary
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.
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.
Study Type
Interventional
Primary Outcome
Number of Participants With Adverse Event ("Global Morbidity"). Secondary Outcome
Postoperative Complications
Condition
Acute Cholecystitis
Intervention
Laparoscopic cholecystectomy
Study Arms / Comparison Groups
Delayed
Description: Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
86
Start Date
February 2009
Completion Date
October 2015
Primary Completion Date
February 2015
Eligibility Criteria
Inclusion Criteria:
- proven echographic cholecystitis
Exclusion Criteria:
- pregnancy
- immunosuppression
- severe sepsis
- perforated cholecystitis
- peritonitis
- cholangitis
- acute pancreatitis
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas Demartines, MD, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT01548339
Organization ID
252/08 CHV
Responsible Party
Principal Investigator
Study Sponsor
University of Lausanne Hospitals
Study Sponsor
Nicolas Demartines, MD, Study Chair, University of Lausanne Hospitals
Verification Date
July 2020