Acute CholecystitisGERBILLENCT06873295
Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Unit in Subjects Over and Under 75 Years
An observational study of Acute Cholecystitis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Cholecystitis
- How many people
- 424 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2023to 22 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the digestive surgery department and geriatric perioperative unit of the CHU de Nîmes with a diagnosis of acute cholecystitis.
Who may be able to join
- Patients over 18 years of age.
- Diagnosis of acute cholecystitis.
- Hospitalization in the digestive surgery department and geriatric perioperative unit of Nîmes University Hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with an initial cold cholecystectomy strategy who did not undergo surgery, died or underwent emergency surgery
Percentage
Measured: Up to 6 months, from date of first collection to date of end of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start22 Mar 2023
- Primary completion22 Oct 2023
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873295
- Sponsor's protocol ID
- Local /2023
- Acronym
- GERBILLE
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06873295
- Acronym / sponsor ID
- GERBILLE / Local /2023
- Conditions
- Acute Cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the digestive surgery department and geriatric perioperative unit of the CHU de Nîmes with a diagnosis of acute cholecystitis.
Key inclusion criteria (3 listed)
- Patients over 18 years of age.
- Diagnosis of acute cholecystitis.
- Hospitalization in the digestive surgery department and geriatric perioperative unit of Nîmes University Hospital.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.