Cholecystectomy, LaparoscopicNCT05728073
Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?
An observational study of Cholecystectomy, Laparoscopic and Cholangiopancreatography, Endoscopic Retrograde, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 470 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2022to 25 Jan 2023
- 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 operated with the diagnosis of acute cholecystitis a single center between January 2016 and December 2019.
Who may be able to join
- Patients operated with the diagnosis of acute cholecystitis with an age greater or equal to 18 years old in a single center between January 2016 and December 2019
Who cannot join
- Initial and direct preferance of open method
- Being diagnosed with malignity after histopathological evaluation
- Being operated just before one week after ERCP or after more than six weeks after ERCP
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırkoy Dr.Sadi Konuk Training and Research Hospital
Istanbul
About this study
Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.
Read the detailed description
The results of patients who underwent surgery for acute cholecystitis in a single center between January 2016 and December 2019 were included and evaluated retrospectively.
Primary outcome was subtotal cholecystectomy rate. Secondary outcomes were conversion to open, complications and serious complications. Within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. Complications that Clavien-Dindo Score ≥ 3 accepted as serious complication. Intraoperative detection of gallbladder perforation was also noted and included in comparison. Any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.
- Being tested
- ERCP
- Keywords
- Acute Cholecystitis, Laparoscopic Subtotal Cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Patients separated to two groups according to having a ERCP history before the operation
| Study group | Role | What they receive |
|---|---|---|
| Standard (non-ERCP) Group | Patients who underwent surgery for acute cholecystitis without a previous ERCP history. | |
| ERCP group | Patients who underwent surgery for acute cholecystitis with a previous ERCP history. Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subtotal Cholecystectomy Rate
Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy
Measured: Intraoperative
Secondary outcomes (1)
Conversion to open
Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start10 Dec 2022
- Primary completion10 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Mehmet Karabulut, Study chair, University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728073
- Sponsor's protocol ID
- 20230205
- Status last verified
- Sep 2023
- First submitted
- 5 Feb 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?
- ClinicalTrials.gov ID
- NCT05728073
- Acronym / sponsor ID
- 20230205
- Keywords
- Acute Cholecystitis, Laparoscopic Subtotal Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 14 Feb 2023 (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.
Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.
Detailed description
The results of patients who underwent surgery for acute cholecystitis in a single center between January 2016 and December 2019 were included and evaluated retrospectively.
Primary outcome was subtotal cholecystectomy rate. Secondary outcomes were conversion to open, complications and serious complications. Within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. Complications that Clavien-Dindo Score ≥ 3 accepted as serious complication. Intraoperative detection of gallbladder perforation was also noted and included in comparison. Any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard (non-ERCP) Group | – | –Patients who underwent surgery for acute cholecystitis without a previous ERCP history. |
| ERCP group | – | Procedure: ERCPPatients who underwent surgery for acute cholecystitis with a previous ERCP history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients operated with the diagnosis of acute cholecystitis a single center between January 2016 and December 2019.
Key inclusion criteria (1 listed)
- Patients operated with the diagnosis of acute cholecystitis with an age greater or equal to 18 years old in a single center between January 2016 and December 2019
Key exclusion criteria (3 listed)
- Initial and direct preferance of open method
- Being diagnosed with malignity after histopathological evaluation
- Being operated just before one week after ERCP or after more than six weeks after ERCP
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 |
|---|---|---|
| ERCPPatients separated to two groups according to having a ERCP history before the operation | Procedure or surgery | ERCP group |
Primary outcome
Subtotal Cholecystectomy Rate
Time frame: Intraoperative
Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy
1 secondary outcome
Conversion to open
Time frame: Intraoperative
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 26 Sep 2023.
- 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.
Mehmet Karabulut study chair
University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research Hospital
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 Cholecystectomy, Laparoscopic and Cholangiopancreatography, Endoscopic Retrograde, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 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 26 Sep 2023. 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?
Subtotal Cholecystectomy Rate (time frame: Intraoperative). 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 26 Sep 2023.