Liver and GIT hospital / Minia university
Minya, Minya Governorate, 61519, Egypt
NCT Number: NCT07137546
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Minya, Minya Governorate, 61519, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intraoperative to 30 days postoperative
Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.
Time frame: Intraoperative
Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI.
Time frame: Intraoperative
Total time from skin incision to closure (minutes).
Time frame: Intraoperative
Time from incision to CVS achievement (minutes).
Time frame: Intraoperative
Proportion of cases where CVS was achieved.
Time frame: Intraoperative
Intraoperative blood loss (mL).
Time frame: Intraoperative
Proportion requiring cholangiography for unclear anatomy or suspected stones.
Time frame: Intraoperative
Incidence of intraoperative gallbladder perforation.
Time frame: Intraoperative
Overall intraoperative complications (e.g., bleeding, perforation, injury).
Time frame: Up to 30 days postoperative
Rate of complications requiring treatment or intervention.
Time frame: Up to 30 days postoperative
Rate of complications requiring surgical intervention under anesthesia.
Time frame: Postoperative
Days from surgery to discharge .
Time frame: 30 days postoperative
Proportion readmitted for complications.
Time frame: Up to 30 days postoperative
Days to resume normal activities
Minia University
Other
Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder
Acronym: FFLC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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