CompletedNot Applicable

Fundus-first Laparoscopic Cholecystectomy

Egypt174 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-80 years * Symptomatic cholelithiasis or cholecystitis requiring laparoscopic cholecystectomy (elective or emergency) * Difficult gallbladder characteristics: Acute cholecystitis (Tokyo Guidelines 2018 Grade II/III), wall thickness \>4 mm on US, pericholecystic fluid, impacted stone in Hartmann's pouch/cystic duct, previous upper abdominal surgery, BMI \>30 kg/m², ≥3 previous cholecystitis episodes, contracted gallbladder, Mirizzi syndrome Type I/II, empyema, severe pericholecystic adhesions on imaging, suspected anatomical variations * The American Society of Anesthesiologists (ASA) physical status I-III * Suitable for laparoscopic approach * Informed consent Exclusion Criteria: * Suspected gallbladder malignancy * Choledocholithiasis requiring endoscopic intervention * Mirizzi syndrome Grade III-IV * Gallbladder perforation with generalized peritonitis * Pregnancy or lactation * Contraindications to laparoscopy (severe cardiopulmonary disease, coagulopathy) * Previous biliary or hepatic surgery * Cirrhosis with portal hypertension * Active coagulopathy * Patient refusal

What they're measuring

Bile Duct Injury Rate

Timeframe: Intraoperative to 30 days postoperative

Trial details

NCT IDNCT07137546

SponsorMinia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01