FrailtyNCT07696078
Frailty is a Risk Factor Postcholecystectomy
A study testing cholecystectomy open in people with Frailty and Gallbladder Diseases, run by Zagazig University.
Trial summary
The goal of this observational study is to learn about the long-term effects of cholecystectomy in patients over the age of 60 who take cholecystectomy to treat their acute cholecystitis). The main question it aims to answer is: Does frailty a risk factor for postcholecystectomy complications? Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty, Gallbladder Diseases
- What is being tested?
- cholecystectomy open
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Apr 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Frailty and Gallbladder Diseases Complications
The goal of this observational study is to learn about the long-term effects of cholecystectomy in patients over the age of 60 who take cholecystectomy to treat their acute cholecystitis). The main question it aims to answer is:
Does frailty a risk factor for postcholecystectomy complications?
- Conditions
- Frailty, Gallbladder Diseases
- Being tested
- cholecystectomy open
- Keywords
- frailty, acute cholecystitis
- Medical subject headings
- Frailty, Gallbladder Diseases, Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomy openProcedure or surgery
frail following open cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| frail patient | Active comparator | Not described Receives: Procedure: cholecystectomy open |
| non frail patient | Active comparator | Not described Receives: Procedure: cholecystectomy open |
What is being measured
The primary outcome is the main question the study is designed to answer.
postcholecystecomy complications
through CD classification
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Apr 2016
- Primary completion1 Apr 2023
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696078
- Sponsor's protocol ID
- frailty and gallbladder
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Gallbladder Diseases Complications
- ClinicalTrials.gov ID
- NCT07696078
- Acronym / sponsor ID
- frailty and gallbladder
- Conditions
- Frailty, Gallbladder Diseases
- Keywords
- frailty, acute cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Jul 2026 (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 goal of this observational study is to learn about the long-term effects of cholecystectomy in patients over the age of 60 who take cholecystectomy to treat their acute cholecystitis). The main question it aims to answer is:
Does frailty a risk factor for postcholecystectomy complications?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frail patient | Active comparator | Procedure: cholecystectomy open |
| non frail patient | Active comparator | Procedure: cholecystectomy open |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecystectomy openfrail following open cholecystectomy | Procedure or surgery | frail patient, non frail patient |
Primary outcome
postcholecystecomy complications
Time frame: 3 years
through CD classification
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 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cholecystectomy open in people with Frailty and Gallbladder Diseases, run by Zagazig University.
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 0 inclusion and 1 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 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
postcholecystecomy complications (time frame: 3 years). 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 10 Jul 2026.