Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
Primary Purpose
Acute Cholecystitis, Cholecystectomy
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- proven echographic cholecystitis
Exclusion Criteria:
- pregnancy
- immunosuppression
- severe sepsis
- perforated cholecystitis
- peritonitis
- cholangitis
- acute pancreatitis
Sites / Locations
- University of Lausanne Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Delayed
Early
Arm Description
Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Laparoscopic cholecystectomy performed directly after the initial diagnosis
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Event ("Global Morbidity").
any adverse event occurring from time of diagnosis until the 30th postoperative day
Secondary Outcome Measures
Postoperative Complications
postoperative complications graded according to Clavien classification
Length of Stay
total in hospital stay
Full Information
NCT ID
NCT01548339
First Posted
March 5, 2012
Last Updated
July 29, 2020
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01548339
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?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Intermediary analysis showing increased morbidity in the delayed group
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis, Cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Arm Title
Early
Arm Type
Experimental
Arm Description
Laparoscopic cholecystectomy performed directly after the initial diagnosis
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
3 trocars laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Event ("Global Morbidity").
Description
any adverse event occurring from time of diagnosis until the 30th postoperative day
Time Frame
30 postoperative days
Secondary Outcome Measure Information:
Title
Postoperative Complications
Description
postoperative complications graded according to Clavien classification
Time Frame
30 postoperative days
Title
Length of Stay
Description
total in hospital stay
Time Frame
30 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
proven echographic cholecystitis
Exclusion Criteria:
pregnancy
immunosuppression
severe sepsis
perforated cholecystitis
peritonitis
cholangitis
acute pancreatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Demartines, MD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nermin Halkic, MD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luca Di Mare, MD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lausanne Hospitals
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27741006
Citation
Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886.
Results Reference
derived
Learn more about this trial
Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
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