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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
174
* 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
* 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
Liver and GIT hospital / Minia university
Minya, Minya Governorate, Egypt
Bile Duct Injury Rate
Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.
Time frame: Intraoperative to 30 days postoperative
Conversion to Open Surgery Rate
Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI.
Time frame: Intraoperative
Operative Time
Total time from skin incision to closure (minutes).
Time frame: Intraoperative
Time to Achieve Critical View of Safety (CVS)
Time from incision to CVS achievement (minutes).
Time frame: Intraoperative
CVS Achievement Rate
Proportion of cases where CVS was achieved.
Time frame: Intraoperative
Estimated Blood Loss
Intraoperative blood loss (mL).
Time frame: Intraoperative
Intraoperative Cholangiography Rate
Proportion requiring cholangiography for unclear anatomy or suspected stones.
Time frame: Intraoperative
Gallbladder Perforation Rate
Incidence of intraoperative gallbladder perforation.
Time frame: Intraoperative
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