Electrosurgical Patterns and Learning Curve in Laparoscopic Gallbladder Surgery
Official title: Electrosurgical Activation Patterns and the Learning Curve in Elective Laparoscopic Cholecystectomy: A Two-Stage Prospective Observational Study
Run by University Hospital of Split · NCT07888491 · Data updated 2026-11-12
This study observes how surgeon experience relates to patterns of electrosurgery use during elective laparoscopic gallbladder removal to see if experience affects intraoperative difficulty.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 165 (estimated) |
| Sponsor | University Hospital of Split Academic / other |
| Locations | 1 site (Split, Split-Dalmatia County) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07888491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult patients undergoing elective laparoscopic cholecystectomy at University Hospital of Split with informed consent.
✕Probably not a fit
Patients undergoing emergency procedures or with conditions that deviate from standard elective care may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, two-stage prospective observational study at the University Hospital of Split. It records electrosurgical activation patterns and audio signals during elective laparoscopic cholecystectomy without changing standard care or techniques. Stage 1 compares 48 operations across eight surgeons with varying experience; Stage 2 follows developing surgeons over 100 operations plus additional cases from beginner and experienced surgeons, aiming for at least 142 evaluable procedures. The analysis focuses on dissection of the hepatocystic triangle and gallbladder separation, using Parkland grading as a measure of intraoperative difficulty. Data are collected via a fixed camera and a directional microphone while standard generator settings are maintained.
Why it matters
Potential benefit: If successful, the study could clarify how experience shapes electrosurgical patterns and intraoperative difficulty, potentially informing training and safety improvements.
How similar studies have gone: Prior work shows that surgeon experience influences procedural performance; this study adds objective electrosurgical and audio data to understand the learning curve in cholecystectomy.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Hospital of Split
Split, Split-Dalmatia County, Croatia Recruiting
Study contacts
- Study coordinator: Ognjen Barcot, MD, PhD
- Email: ognjen.barcot@kbsplit.hr
- Phone: +385 21 556 691
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.