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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
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 5, 2012
Last Updated
July 29, 2020
Sponsor
University of Lausanne Hospitals
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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

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Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

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