Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Liver and GIT hospital / Minia university
RECRUITING
Minya
Contact Information
Primary
Saleh K Saleh, MD
salehkhairy@mu.edu.eg
01201765401
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 174
Treatments
Experimental: Fundus-First Laparoscopic Cholecystectomy ( FFLC)
Laparoscopic cholecystectomy starting dissection at the gallbladder fundus, progressing retrograde toward the cystic duct/artery. Critical View of Safety (CVS) confirmed before duct division.
Active_comparator: Classical Laparoscopic Cholecystectomy (CLC)
The standard critical view of safety technique (anterior-posterior dissection of Calot's triangle first).
Sponsors
Leads: Minia University

This content was sourced from clinicaltrials.gov