Acute Cholecystitis, Cholecystitis, Pericholecystic Abscess
Conditions
Keywords
Fundus-first laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy, Bile duct injury, Difficult gallbladder, Critical view of safety
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 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.
Interventions
PROCEDUREFundus-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
PROCEDUREClassical 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
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bile Duct Injury Rate | Intraoperative to 30 days postoperative | Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Cholangiography Rate | Intraoperative | Proportion requiring cholangiography for unclear anatomy or suspected stones. |
| Gallbladder Perforation Rate | Intraoperative | Incidence of intraoperative gallbladder perforation. |
| Conversion to Open Surgery Rate | Intraoperative | Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI. |
| Operative Time | Intraoperative | Total time from skin incision to closure (minutes). |
| Time to Achieve Critical View of Safety (CVS) | Intraoperative | Time from incision to CVS achievement (minutes). |
| Estimated Blood Loss | Intraoperative | Intraoperative blood loss (mL). |
| CVS Achievement Rate | Intraoperative | Proportion of cases where CVS was achieved. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD
Minia University
Outcome results
None listed