Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

July 29, 2020 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • University of Lausanne Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • proven echographic cholecystitis

Exclusion Criteria:

  • pregnancy
  • immunosuppression
  • severe sepsis
  • perforated cholecystitis
  • peritonitis
  • cholangitis
  • acute pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Delayed
Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy
Experimental: Early
Laparoscopic cholecystectomy performed directly after the initial diagnosis
Procedure: Laparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Event ("Global Morbidity").
Time Frame: 30 postoperative days
any adverse event occurring from time of diagnosis until the 30th postoperative day
30 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: 30 postoperative days
postoperative complications graded according to Clavien classification
30 postoperative days
Length of Stay
Time Frame: 30 postoperative days
total in hospital stay
30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 252/08 CHV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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