CholelithiasisNCT06244589
Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery
A study testing Laparoscopic cholecystectomy and Open-conversion cholecystectomy in people with Cholelithiasis and Cholecystitis, Acute, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. Patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cholelithiasis, Cholecystitis, Acute, Cholecystitis, Chronic
- What is being tested?
- Laparoscopic cholecystectomy and Open-conversion cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,695 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 28 May 2024
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 95 years old.
- Operated for gallbladder disease (Cholecystectomy)
- Surgery must started with laparoscopic approach
Who cannot join
- Open surgery from the start
- Cholecystectomy as a part of bigger surgical intervention (Such as pancreaticoduodenectomy)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Research and Training Hospital
Istanbul
About this study
Official title: Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study
This retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. Patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed.
Read the detailed description
Cholecystectomy is a commonly performed procedure in general surgical practice, and with advancements in technology, it is widely conducted using the laparoscopic method. Despite the decreasing trend in open surgical procedures with increasing experience and technological developments, the literature reports conversion to open surgery in laparoscopic cholecystectomy ranging from 2% to 15%. Although some studies exist regarding patient groups at risk of conversion to open surgery, the current literature is insufficient to draw a clear conclusion on this matter. This study aims to evaluate risk factors for conversion to open surgery by examining cases of laparoscopically initiated cholecystectomy.
The study will be conducted retrospectively by reviewing archive records. Patients operated for cholecystectomy will be included. Patients that open surgical method used from start will be excluded from study. Age, comorbidities (ASA score), laboratory findings (leukocyte count and CRP), imaging findings (abdominal ultrasound, CT, or MRI), history of previous abdominal surgery, history of ERCP, and history of pancreatitis will be evaluated. Laparoscopic cholecystectomy cases will be compared with open-conversion cholecystectomies to assess factors influencing the conversion.
- Being tested
- Laparoscopic cholecystectomy, Open-conversion cholecystectomy
- Keywords
- Laparoscopic cholecystectomy, Conversion, Cholelithiasis, Acute cholecystitis
- Medical subject headings
- Cholelithiasis, Cholecystitis, Acute, Cholecystitis, Bronchiolitis Obliterans Syndrome, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method
Open-conversion cholecystectomyProcedure or surgery
Open-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy | Active comparator | Cases that laparoscopic cholecystectomy performed without need for open-conversion Receives: Procedure: Laparoscopic cholecystectomy |
| Open-conversion cholecystectomy | Experimental | Cases converted to open surgery based on intraoperative findings. Receives: Procedure: Laparoscopic cholecystectomy; Procedure: Open-conversion cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open-conversion rate
The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.
Measured: Immediately after the surgery
Secondary outcomes (2)
Postoperative complication rate
The rate of postoperative complications
Measured: 1 months after the surgery
Incidental gallbladder malignancy rate
The rate of incidentally diagnosed gallbladder cancer among all laparoscopic cholecystectomies in patients without a preoperative diagnosis.
Measured: 1 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start12 Feb 2024
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study aims to compare cases of laparoscopic cholecystectomy with those undergoing open-conversion cholecystectomy to assess factors influencing the conversion to open surgery.
- Masking
- None (open label)
- Enrolment
- 1,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Dincer, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Burak Dincer, M.D., Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244589
- Sponsor's protocol ID
- 16.01.2024-4240
- Status last verified
- May 2024
- First submitted
- 29 Jan 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dincer B, Omeroglu S, Tufan AE, Uzun MA. Evaluation of Risk Factors Leading to Conversion from Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study. J Laparoendosc Adv Surg Tech A. 2025 Mar;35(3):204-209. doi: 10.1089/lap.2024.0366. Epub 2025 Feb 24.
PubMed 39992726
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study
- ClinicalTrials.gov ID
- NCT06244589
- Acronym / sponsor ID
- 16.01.2024-4240
- Keywords
- Laparoscopic cholecystectomy, Conversion, Cholelithiasis, Acute cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,695 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 6 Feb 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.
This retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. Patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed.
Detailed description
Cholecystectomy is a commonly performed procedure in general surgical practice, and with advancements in technology, it is widely conducted using the laparoscopic method. Despite the decreasing trend in open surgical procedures with increasing experience and technological developments, the literature reports conversion to open surgery in laparoscopic cholecystectomy ranging from 2% to 15%. Although some studies exist regarding patient groups at risk of conversion to open surgery, the current literature is insufficient to draw a clear conclusion on this matter. This study aims to evaluate risk factors for conversion to open surgery by examining cases of laparoscopically initiated cholecystectomy.
The study will be conducted retrospectively by reviewing archive records. Patients operated for cholecystectomy will be included. Patients that open surgical method used from start will be excluded from study. Age, comorbidities (ASA score), laboratory findings (leukocyte count and CRP), imaging findings (abdominal ultrasound, CT, or MRI), history of previous abdominal surgery, history of ERCP, and history of pancreatitis will be evaluated. Laparoscopic cholecystectomy cases will be compared with open-conversion cholecystectomies to assess factors influencing the conversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study aims to compare cases of laparoscopic cholecystectomy with those undergoing open-conversion cholecystectomy to assess factors influencing the conversion to open surgery.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyCases that laparoscopic cholecystectomy performed without need for open-conversion |
| Open-conversion cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomy, Procedure: Open-conversion cholecystectomyCases converted to open surgery based on intraoperative findings. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 95 years old.
- Operated for gallbladder disease (Cholecystectomy)
- Surgery must started with laparoscopic approach
Key exclusion criteria (2 listed)
- Open surgery from the start
- Cholecystectomy as a part of bigger surgical intervention (Such as pancreaticoduodenectomy)
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 |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method | Procedure or surgery | Laparoscopic cholecystectomy, Open-conversion cholecystectomy |
| Open-conversion cholecystectomyOpen-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings. | Procedure or surgery | Open-conversion cholecystectomy |
Primary outcome
Open-conversion rate
Time frame: Immediately after the surgery
The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.
2 secondary outcomes
Postoperative complication rate
Time frame: 1 months after the surgery
Incidental gallbladder malignancy rate
Time frame: 1 months after the surgery
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 29 May 2024.
- Derived from this study: PubMed 39992726Dincer B, Omeroglu S, Tufan AE, Uzun MA. Evaluation of Risk Factors Leading to Conversion from Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study. J Laparoendosc Adv Surg Tech A. 2025 Mar;35(3):204-209. doi: 10.1089/lap.2024.0366. Epub 2025 Feb 24.
- Individual participant dataSharing planned: No
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
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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.
Burak Dincer, M.D. principal investigator
Sisli Hamidiye Etfal 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?
A study testing Laparoscopic cholecystectomy and Open-conversion cholecystectomy in people with Cholelithiasis and Cholecystitis, Acute, run by Sisli Hamidiye Etfal 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 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 29 May 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?
Open-conversion rate (time frame: Immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244589, which also lists 1 linked publication.
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 29 May 2024.