NCT07137546

Fundus-first Laparoscopic Cholecystectomy

Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bile duct injury (BDI) rates remain 0.3-1.5% in difficult gallbladders. FFLC avoids early dissection near critical structures, potentially lowering BDI risk. This randomized controlled trial aims to compare the safety and efficacy of fundus-first (FF) versus classical (Calot-first) laparoscopic cholecystectomy techniques in patients with difficult gallbladders. The study will evaluate perioperative outcomes, conversion rates, complications, and operative time between the two surgical approaches. Based on recent evidence suggesting an improved safety profile with the fundus-first technique, we hypothesize that the FF approach will demonstrate reduced bile duct injury rates and improved surgical outcomes in difficult cases.

Conditions

• Cholecystitis
• Acute Cholecystitis
• Pericholecystic Abscess

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-02-01
• Completion: 2026-02-17
• First posted: 2025-08-22
• Last updated: 2026-02-19

Locations

1 site across 1 country: Egypt