NCT07113704

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

July 25, 2025

Last Update Submit

August 2, 2025

Conditions

Keywords

fundus-first laparoscopic cholecystectomydifficult cholecystectomyCross-sectional studyGeneral surgeryLaparoscopic cholecystectomyTertiary care hospital

Outcome Measures

Primary Outcomes (1)

  • Conversion Rate to Open Surgery

    Rate of conversion from laparoscopic to open cholecystectomy in each group. Measured as number and percentage of patients converted.

    Intraoperative (during surgery)

Secondary Outcomes (3)

  • Operative Time

    Intraoperative (during surgery)

  • Postoperative Complication Rate

    Within 30 days postoperatively

  • Length of Hospital Stay

    Postoperative hospitalization

Study Arms (2)

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.

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.

Procedure: Fundus-First Laparoscopic Cholecystectomy

Interventions

Standard laparoscopic cholecystectomy technique starting at Calot's triangle. Used as the comparator group in this study.

Also known as: Antegrade Laparoscopic Cholecystectomy
Conventional 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.

Also known as: Retrograde laparoscopic cholecystectomy
Fundus-First Laparoscopic Cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with incomplete medical records
  • Patients undergoing open cholecystectomy from the beginning
  • Patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicana Ataşehir International Hospital

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • KANAN ISMAYILZADA, MD

    Medicana Ataşehir International Hospital, ISTANBUL.TURKEY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 11, 2025

Study Start

January 5, 2023

Primary Completion

April 1, 2024

Study Completion

April 10, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The study is retrospective in nature, and no plans have been made to share individual participant data with other researchers.

Locations