Status:
ACTIVE_NOT_RECRUITING
Fundus-first Laparoscopic Cholecystectomy
Lead Sponsor:
Minia University
Conditions:
Cholecystitis
Acute Cholecystitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT07137546
Start Date
May 1 2024
End Date
January 1 2026
Last Update
December 5 2025
Active Locations (1)
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1
Liver and GIT hospital / Minia university
Minya, Minya Governorate, Egypt, 61519