Fundus-first Laparoscopic Cholecystectomy

NCT07137546 | Completed DMC

• 1 other identifier: 1131/04/2024
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis; Acute Cholecystitis; Pericholecystic Abscess

Keywords

Fundus-first laparoscopic cholecystectomy; Conventional laparoscopic cholecystectomy; Bile duct injury; Difficult gallbladder; Critical view of safety

Outcome Measures

Primary Outcomes (1)

• Bile Duct Injury Rate

  Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.

  Intraoperative to 30 days postoperative

Secondary Outcomes (7)

• Conversion to Open Surgery Rate

  Intraoperative

• Operative Time

  Intraoperative

• Time to Achieve Critical View of Safety (CVS)

  Intraoperative

• CVS Achievement Rate

  Intraoperative

• Estimated Blood Loss

  Intraoperative

Other Outcomes (6)

• Intraoperative Complications Rate

  Intraoperative

• Postoperative Complications

  Up to 30 days postoperative

• Major Postoperative Complications

  Up to 30 days postoperative

Study Arms (2)

Fundus-First Laparoscopic Cholecystectomy ( FFLC)

EXPERIMENTAL

Laparoscopic cholecystectomy starting dissection at the gallbladder fundus, progressing retrograde toward the cystic duct/artery. Critical View of Safety (CVS) confirmed before duct division.

Procedure: Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Classical Laparoscopic Cholecystectomy (CLC)

ACTIVE COMPARATOR

The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first).

Procedure: Classical Laparoscopic Cholecystectomy (CLC)

Interventions

Fundus-First Laparoscopic Cholecystectomy ( FFLC) PROCEDURE

* 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

Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Classical Laparoscopic Cholecystectomy (CLC) PROCEDURE

* 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

Classical Laparoscopic Cholecystectomy (CLC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital / Minia university

Minya, Minya Governorate, 61519, Egypt

Location

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: May 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 17, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

EG (1)