Fundus-first Laparoscopic Cholecystectomy
NCT07137546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2026-02-19
Summary
Bile duct injury (BDI) remains the most feared complication of laparoscopic cholecystectomy, particularly in difficult gallbladder cases. The fundus-first technique has emerged as a potentially safer alternative to classical laparoscopic cholecystectomy for challenging cases. This single-center, prospective, randomized controlled trial compared the efficacy and safety of fundus-first laparoscopic cholecystectomy (FF-LC) versus classical laparoscopic cholecystectomy (C-LC) in 174 patients with difficult gallbladder characteristics. The primary outcome was bile duct injury rate. Secondary outcomes included conversion to open surgery, operative parameters, and postoperative complications.
Conditions
- Cholecystitis
- Acute Cholecystitis
- Pericholecystic Abscess
Interventions
- PROCEDURE
-
Fundus-First Laparoscopic Cholecystectomy ( FFLC)
* Standard 4-port laparoscopic setup * Carbon dioxide (CO₂) pneumoperitoneum (12-15 mmHg) * Dissection begins at gallbladder fundus * Peritoneum incised from infundibulum to fundus along liver bed * Gallbladder dissected from fundus toward infundibulum * Cystic artery and duct identified and divided last * Critical view of safety achieved before vessel division
- PROCEDURE
-
Classical Laparoscopic Cholecystectomy (CLC)
* Standard 4-port laparoscopic setup * Carbon dioxide (CO₂) pneumoperitoneum (12-15 mmHg) * Dissection begins at Calot's triangle * Critical view of safety achieved first * Cystic artery and duct divided before gallbladder bed dissection * Gallbladder dissected from liver bed
Sponsors & Collaborators
-
Minia University
lead OTHER
Principal Investigators
-
Saleh K Saleh, MD · Minia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2026-02-01
- Completion
- 2026-02-17
Countries
- Egypt
Study Locations
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