CholelithiasisNCT07113704
Fundus-First Laparoscopic Cholecystectomy in Difficult Gallbladders: A Safe Alternative Technique
An observational study of Cholelithiasis, run by KANAN ISMAYILZADA, MD at 1 site in Turkey (Türkiye).
Trial summary
This retrospective cross-sectional study evaluated the safety and effectiveness of the fundus-first laparoscopic cholecystectomy (FFLC) technique in patients with difficult gallbladders. A total of 124 patients who underwent FFLC between 2023 and 2024 were reviewed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Conventional Laparoscopic Cholecystectomy and Fundus-First Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 10 Apr 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: This study included adult patients (≥18 years) who underwent laparoscopic cholecystectomy for difficult gallbladder (Nassar grade 3-4) at a single tertiary care center between January 2023 and March 2024.
Who may be able to join
- Patients who underwent laparoscopic cholecystectomy at the study center between January 2023 and March 2024
- Patients diagnosed with difficult gallbladder (Nassar Grade 3-4)
- Age ≥ 18 years
- Complete clinical data available for analysis
Who cannot join
- Patients with incomplete medical records
- Patients undergoing open cholecystectomy from the beginning
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medicana Ataşehir International Hospital
Istanbul, Ataşehir, 34750
About this study
Official title: Fundus-First Laparoscopic Cholecystectomy in Difficult Gallbladders: A Retrospective Cross-Sectional Study on a Safe Alternative to Avoid Conversion
This retrospective cross-sectional study evaluated the safety and effectiveness of the fundus-first laparoscopic cholecystectomy (FFLC) technique in patients with difficult gallbladders. A total of 124 patients who underwent FFLC between 2023 and 2024 were reviewed. The study assessed operative time, intraoperative complications, conversion rates, and postoperative outcomes. The results suggest that FFLC is a safe and feasible approach that can reduce the need for conversion to open surgery in complex cases. The study was conducted at a private hospital in Istanbul, Turkey
Read the detailed description
This retrospective study was conducted at a private healthcare institution without a formal IRB. All patient data were anonymised before analysis, and written informed consent was obtained from all patients for the academic use of their clinical data
- Conditions
- Cholelithiasis
- Being tested
- Conventional Laparoscopic Cholecystectomy, Fundus-First Laparoscopic Cholecystectomy
- Keywords
- fundus-first laparoscopic cholecystectomy, difficult cholecystectomy, Cross-sectional study, General surgery, Laparoscopic cholecystectomy, Tertiary care hospital
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Laparoscopic CholecystectomyProcedure or surgery
Also called Antegrade Laparoscopic Cholecystectomy
Standard laparoscopic cholecystectomy technique starting at Calot's triangle. Used as the comparator group in this study.
Fundus-First Laparoscopic CholecystectomyProcedure or surgery
Also called Retrograde laparoscopic cholecystectomy
Laparoscopic cholecystectomy technique initiated at the gallbladder fundus and carried out retrogradely toward Calot's triangle. This method was applied to difficult gallbladders (Nassar Grade 3-4) to improve operative safety and avoid conversion to open surgery.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Laparoscopic Cholecystectomy | Patients who underwent standard laparoscopic cholecystectomy, starting dissection at Calot's triangle. This technique served as the comparator for assessing safety and conversion rates relative to the fundus-first approach. Receives: Procedure: Conventional Laparoscopic Cholecystectomy | |
| Fundus-First Laparoscopic Cholecystectomy | Patients with difficult gallbladders (Nassar Grade 3-4) who underwent laparoscopic cholecystectomy using the fundus-first technique. This approach involved starting dissection at the gallbladder fundus and proceeding retrogradely toward Calot's triangle to improve safety in complex cases. Receives: Procedure: Fundus-First Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion Rate to Open Surgery
Rate of conversion from laparoscopic to open cholecystectomy in each group. Measured as number and percentage of patients converted.
Measured: Intraoperative (during surgery)
Secondary outcomes (3)
Operative Time
Total operative time measured in minutes from skin incision to closure. Comparison between the fundus-first and conventional laparoscopic cholecystectomy groups.
Measured: Intraoperative (during surgery)
Postoperative Complication Rate
Includes complications such as wound infection, bile leak, abscess, or any adverse event requiring medical or surgical intervention. Compared between groups
Measured: Within 30 days postoperatively
Length of Hospital Stay
Number of days from surgery to discharge. Mean values will be compared between groups.
Measured: Postoperative hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start5 Jan 2023
- Primary completion1 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- KANAN ISMAYILZADA, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, KANAN ISMAYILZADA, MD, Medicana Ataşehir International Hospital
- Investigators
- KANAN ISMAYILZADA, MD, Principal investigator, Medicana Ataşehir International Hospital, ISTANBUL.TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113704
- Sponsor's protocol ID
- FFLC2025AMSUKI
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is retrospective in nature, and no plans have been made to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundus-First Laparoscopic Cholecystectomy in Difficult Gallbladders: A Retrospective Cross-Sectional Study on a Safe Alternative to Avoid Conversion
- ClinicalTrials.gov ID
- NCT07113704
- Acronym / sponsor ID
- FFLC2025AMSUKI
- Conditions
- Cholelithiasis
- Keywords
- fundus-first laparoscopic cholecystectomy, difficult cholecystectomy, Cross-sectional study, General surgery, Laparoscopic cholecystectomy, Tertiary care hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- KANAN ISMAYILZADA, MDUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 11 Aug 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.
This retrospective cross-sectional study evaluated the safety and effectiveness of the fundus-first laparoscopic cholecystectomy (FFLC) technique in patients with difficult gallbladders. A total of 124 patients who underwent FFLC between 2023 and 2024 were reviewed. The study assessed operative time, intraoperative complications, conversion rates, and postoperative outcomes. The results suggest that FFLC is a safe and feasible approach that can reduce the need for conversion to open surgery in complex cases. The study was conducted at a private hospital in Istanbul, Turkey
Detailed description
This retrospective study was conducted at a private healthcare institution without a formal IRB. All patient data were anonymised before analysis, and written informed consent was obtained from all patients for the academic use of their clinical data
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Laparoscopic Cholecystectomy | – | Procedure: Conventional Laparoscopic CholecystectomyPatients who underwent standard laparoscopic cholecystectomy, starting dissection at Calot's triangle. This technique served as the comparator for assessing safety and conversion rates relative to the fundus-first approach. |
| Fundus-First Laparoscopic Cholecystectomy | – | Procedure: Fundus-First Laparoscopic CholecystectomyPatients with difficult gallbladders (Nassar Grade 3-4) who underwent laparoscopic cholecystectomy using the fundus-first technique. This approach involved starting dissection at the gallbladder fundus and proceeding retrogradely toward Calot's triangle to improve safety in complex cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included adult patients (≥18 years) who underwent laparoscopic cholecystectomy for difficult gallbladder (Nassar grade 3-4) at a single tertiary care center between January 2023 and March 2024.
Key inclusion criteria (4 listed)
- Patients who underwent laparoscopic cholecystectomy at the study center between January 2023 and March 2024
- Patients diagnosed with difficult gallbladder (Nassar Grade 3-4)
- Age ≥ 18 years
- Complete clinical data available for analysis
Key exclusion criteria (3 listed)
- Patients with incomplete medical records
- Patients undergoing open cholecystectomy from the beginning
- Patients under 18 years of age
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 |
|---|---|---|
| Conventional Laparoscopic CholecystectomyAlso: Antegrade Laparoscopic CholecystectomyStandard laparoscopic cholecystectomy technique starting at Calot's triangle. Used as the comparator group in this study. | Procedure or surgery | Conventional Laparoscopic Cholecystectomy |
| Fundus-First Laparoscopic CholecystectomyAlso: Retrograde laparoscopic cholecystectomyLaparoscopic cholecystectomy technique initiated at the gallbladder fundus and carried out retrogradely toward Calot's triangle. This method was applied to difficult gallbladders (Nassar Grade 3-4) to improve operative safety and avoid conversion to open surgery. | Procedure or surgery | Fundus-First Laparoscopic Cholecystectomy |
Primary outcome
Conversion Rate to Open Surgery
Time frame: Intraoperative (during surgery)
Rate of conversion from laparoscopic to open cholecystectomy in each group. Measured as number and percentage of patients converted.
3 secondary outcomes
Operative Time
Time frame: Intraoperative (during surgery)
Postoperative Complication Rate
Time frame: Within 30 days postoperatively
Length of Hospital Stay
Time frame: Postoperative hospitalization
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 11 Aug 2025.
- Individual participant dataSharing planned: No. The study is retrospective in nature, and no plans have been made to share individual participant data with other researchers.
Related trials for Cholelithiasis
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in 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.
KANAN ISMAYILZADA, MD principal investigator
Medicana Ataşehir International Hospital, ISTANBUL.TURKEY
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 Cholelithiasis, run by KANAN ISMAYILZADA, MD 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 4 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 11 Aug 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 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?
Conversion Rate to Open Surgery (time frame: Intraoperative (during surgery)). 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 11 Aug 2025.