Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Unit in Subjects Over and Under 75 Years (GERBILLE)

March 11, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Evaluation of the Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Intraoperative Unit in Subjects Over and Under 75 Years of Age

The management of these often frail elderly patients, with more comorbidities and declining functional capacities, is more complex and justifies a specific, tailored approach.

Age is also associated with an increasing prevalence of gallstones. The disadvantages of "cold" surgery (longer hospital stay, higher cost, risk of disease recurrence in the interim, difficult surgery with more scar tissue due to repeated inflammation) have to be weighed against the high operative risk in the case of emergency surgery, leading to strict criteria for early cholecystectomy.

These criteria are rarely met in geriatric patients, who thus enter a hospital cycle whose impact on morbidity and mortality, as well as on loss of autonomy, has been demonstrated in this population. What's more, the deteriorating general condition of frail elderly patients means that a number of them end up being definitively rejected for surgery, despite an initial strategy of cold cholecystectomy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

424

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

  • France
      • Nîmes, France
        • Simonet Anne Clarisse

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in the digestive surgery department and geriatric perioperative unit of the CHU de Nîmes with a diagnosis of acute cholecystitis.

Description

Inclusion Criteria:

  • Patients over 18 years of age.
  • Diagnosis of acute cholecystitis.
  • Hospitalization in the digestive surgery department and geriatric perioperative unit of Nîmes University Hospital.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Opposition of the patient to his inclusion in the study after sending the letter of information and non-opposition.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with an initial cold cholecystectomy strategy who did not undergo surgery, died or underwent emergency surgery
Time Frame: Up to 6 months, from date of first collection to date of end of collection
Percentage
Up to 6 months, from date of first collection to date of end of collection

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

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 (Actual)

March 22, 2023

Primary Completion (Actual)

October 22, 2023

Study Completion (Actual)

October 22, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local /2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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