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Recruiting NCT07888491

Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy

Conditions: Cholelithiasis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 165
Sponsor: University Hospital of Split

Location: University Hospital of Split Split Split-Dalmatia County

Summary

This prospective observational study will examine how electrosurgical activation patterns during elective laparoscopic cholecystectomy are associated with surgeon experience and intraoperative difficulty. Adult patients scheduled for elective laparoscopic cholecystectomy at University Hospital of Split will receive standard clinical care; the study does not assign an intervention or change the surgical technique. A fixed camera will record only the laparoscopic monitor, and a directional microphone will record the audible signals of the electrosurgical generator. The study includes a cross-sectional comparison among surgeons with different cumulative experience and a longitudinal assessment of developing surgeons as they gain additional experience. Activation patterns will be analyzed separately during dissection of the hepatocystic triangle and separation of the gallbladder from the liver bed. Intraoperative difficulty will be graded from the initial operative video using the Parkland Grading Scale by two independent assessors, with adjudication when needed.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Elective laparoscopic cholecystectomy in the regular operating program * Written informed consent * The designated study surgeon performs the entire analyzed operative segment * Technically usable synchronized audio-video recording with known electrosurgical generator settings and instrument Exclusion Criteria: * Emergency surgery or clinical acute cholecystitis as the indication for surgery * Previous endoscopic retrograde cholangiopancreatography (ERCP) * Previous upper abdominal surgery * Open cholecystectomy from the outset or a major combined operation that materially alters the operative course * Predominant use of another energy device that is not comparable with the standardized generator * Change or takeover of the operating surgeon within the analyzed segment without the possibility of clear separation * Technically unusable audio or video recording or missing initial image required for Parkland grading * Withdrawal of informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07888491). StuddyBuddy aggregates publicly available trial information.