Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Classical Laparoscopic Cholecystectomy (CLC) | Active Comparator | The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fundus-First Laparoscopic Cholecystectomy ( FFLC) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bile Duct Injury Rate | Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging. | Intraoperative to 30 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to Open Surgery Rate | Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI. | Intraoperative |
| Operative Time | Total time from skin incision to closure (minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Complications Rate | Overall intraoperative complications (e.g., bleeding, perforation, injury). | Intraoperative |
| Postoperative Complications | Rate of complications requiring treatment or intervention. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Saleh K Saleh, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver and GIT hospital / Minia university | Minya | Minya Governorate | 61519 | Egypt |
Not provided
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
|
| Classical Laparoscopic Cholecystectomy (CLC) | Procedure |
|
|
| Intraoperative |
| Time to Achieve Critical View of Safety (CVS) | Time from incision to CVS achievement (minutes). | Intraoperative |
| CVS Achievement Rate | Proportion of cases where CVS was achieved. | Intraoperative |
| Estimated Blood Loss | Intraoperative blood loss (mL). | Intraoperative |
| Intraoperative Cholangiography Rate | Proportion requiring cholangiography for unclear anatomy or suspected stones. | Intraoperative |
| Gallbladder Perforation Rate | Incidence of intraoperative gallbladder perforation. | Intraoperative |
| Up to 30 days postoperative |
| Major Postoperative Complications | Rate of complications requiring surgical intervention under anesthesia. | Up to 30 days postoperative |
| Length of Hospital Stay | Days from surgery to discharge . | Postoperative |
| Readmission Rate Within 30 Days | Proportion readmitted for complications. | 30 days postoperative |
| Time to Return to Normal Activity | Days to resume normal activities | Up to 30 days postoperative |