NCT06873295

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

June 22, 2023

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with an initial cold cholecystectomy strategy who did not undergo surgery, died or underwent emergency surgery

    Percentage

    Up to 6 months, from date of first collection to date of end of collection

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simonet Anne Clarisse

Nîmes, France

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

March 12, 2025

Study Start

March 22, 2023

Primary Completion

October 22, 2023

Study Completion

October 22, 2024

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations