Acute CholecystitisNCT06743217
TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMIES IN ELDERLY PATIENTS
An observational study of Acute Cholecystitis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Textbook outcome is a measure used to assess the quality of surgical practice. The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\<65 years ) via using aforementioned criteria Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- How many people
- 212 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 15 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 18 years old and underwent emergency cholecystectomy
Who may be able to join
- All patients underwent emergency cholecystectomy with a diagnosis of acute choleystitis
Who cannot join
- Patients underwent open surgery directly. Patients diagnosed as malignant postoperatively in the pathology report
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery
Istanbul, 34303
About this study
Official title: IS THERE A DIFFERENCE IN TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMY IN ELDERLY PATIENTS COMPARED TO OTHERS
Textbook outcome is a measure used to assess the quality of surgical practice. The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\<65 years ) via using aforementioned criteria
Read the detailed description
Textbook outcome is a measure used to assess the quality of surgical practice and has been implemented in various areas of surgical literature. It is defined as an uneventful operative and postoperative period that leads to successful surgery without negative outcomes. There is still no consensus on the textbook outcome concept for emergency cholecystectomy. SPRIMACC Collaborative Study has presented and offered a list of textbook outcome criteria.
Their proposal was: no 30-day mortality, no 30-day postoperative complications (any CD≥I is considered non-TO), no readmission within 30 days, and hospital stay≤7 days (75th percentile) and full laparoscopic surgery.
The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\<65 years ) via using aforementioned criteria
- Conditions
- Acute Cholecystitis
- Keywords
- Acute Cholecystitis, Textbook Outcome, Emergency Surgery
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | All patients which are younger than 65 years old and underwent emergency cholecystectomy between 2020 and 2024 | |
| Group B- Elderly Group | All patients ≥ 65 years old and underwent emergency cholecystectomy between 2020 and 2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook Outcome
The Textbook Outcome criteria for emergency cholecystectomy in this study were patients have these criteria: no 30-day mortality, no 30-day postoperative complications, no readmission within 30 days, hospital stay≤7 days and full laparoscopic surgery
Measured: 30 days
Secondary outcomes (2)
Subtotal cholecystectomy
Patients underwent emergency surgery with a diagnosis of acute cholecystitis and subtotal cholecystectoym performed
Measured: 1 day
Postoperative Serious Complications
Postoperative complications that have a Clavien-Dindo Score ≥3 were accepted as serious complication.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Sep 2024
- Primary completion15 Sep 2024
- Study completion15 Sep 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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasir Musa Kesgin, MD, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Yasir Musa Kesgin, MD, Study chair, University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery, Istanbul,Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743217
- Sponsor's protocol ID
- 2024-165
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS THERE A DIFFERENCE IN TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMY IN ELDERLY PATIENTS COMPARED TO OTHERS
- ClinicalTrials.gov ID
- NCT06743217
- Acronym / sponsor ID
- 2024-165
- Conditions
- Acute Cholecystitis
- Keywords
- Acute Cholecystitis, Textbook Outcome, Emergency Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 19 Dec 2024 (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.
Textbook outcome is a measure used to assess the quality of surgical practice. The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\<65 years ) via using aforementioned criteria
Detailed description
Textbook outcome is a measure used to assess the quality of surgical practice and has been implemented in various areas of surgical literature. It is defined as an uneventful operative and postoperative period that leads to successful surgery without negative outcomes. There is still no consensus on the textbook outcome concept for emergency cholecystectomy. SPRIMACC Collaborative Study has presented and offered a list of textbook outcome criteria.
Their proposal was: no 30-day mortality, no 30-day postoperative complications (any CD≥I is considered non-TO), no readmission within 30 days, and hospital stay≤7 days (75th percentile) and full laparoscopic surgery.
The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\<65 years ) via using aforementioned criteria
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –All patients which are younger than 65 years old and underwent emergency cholecystectomy between 2020 and 2024 |
| Group B- Elderly Group | – | –All patients ≥ 65 years old and underwent emergency cholecystectomy between 2020 and 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years old and underwent emergency cholecystectomy
Key inclusion criteria (1 listed)
- All patients underwent emergency cholecystectomy with a diagnosis of acute choleystitis
Key exclusion criteria (1 listed)
- Patients underwent open surgery directly. Patients diagnosed as malignant postoperatively in the pathology report
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
Textbook Outcome
Time frame: 30 days
The Textbook Outcome criteria for emergency cholecystectomy in this study were patients have these criteria: no 30-day mortality, no 30-day postoperative complications, no readmission within 30 days, hospital stay≤7 days and full laparoscopic surgery
2 secondary outcomes
Subtotal cholecystectomy
Time frame: 1 day
Postoperative Serious Complications
Time frame: 30 days
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 19 Dec 2024.
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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.
Yasir Musa Kesgin, MD study chair
University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery, Istanbul,Türkiye
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 Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 19 Dec 2024. 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 Turkey (Türkiye). 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?
Textbook Outcome (time frame: 30 days). 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 19 Dec 2024.