Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy

NCT07888491 | Recruiting

• 1 other identifier: KBCST-ELECTROLC-2026-01
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholelithiasis

Keywords

Laparoscopic cholecystectomy; Electrosurgery; Surgical learning curve; Parkland Grading Scale; Audio analysis

Outcome Measures

Primary Outcomes (2)

• Median Duration of Coagulation-Mode Electrosurgical Activations During Segment A

  For each operation, the median duration in seconds of individual, clearly separated coagulation-mode activations detected by the locked audio-analysis algorithm during hepatocystic triangle dissection (Segment A). Segment A must contain at least three coagulation-mode activations. The operation is the unit of analysis.

  During Segment A of the index laparoscopic cholecystectomy

• Longitudinal Change in Median Coagulation Activation Duration During Segment A

  Change in the operation-level median duration of individual coagulation-mode activations during Segment A for the four longitudinally followed developing surgeons, estimated per 10 additional evaluable laparoscopic cholecystectomies. The effect will be reported as absolute and percentage change with a 95% confidence interval, adjusted for Parkland grade.

  From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028

Secondary Outcomes (13)

• Number of Coagulation-Mode Activations per Minute by Operative Segment

  During Segments A and B of the index laparoscopic cholecystectomy

• Total Coagulation Activation Time per Minute by Operative Segment

  During Segments A and B of the index laparoscopic cholecystectomy

• Variability of Coagulation Activation Duration by Operative Segment

  During Segments A and B of the index laparoscopic cholecystectomy

• Proportion of Coagulation Activations Longer Than 2 Seconds by Operative Segment

  During Segments A and B of the index laparoscopic cholecystectomy

• Median Inter-Activation Interval by Operative Segment

  During Segments A and B of the index laparoscopic cholecystectomy

Study Arms (1)

Elective Laparoscopic Cholecystectomy Cohort

Adult patients undergoing elective laparoscopic cholecystectomy under standard clinical care. Consecutive eligible cases will be enrolled within predefined surgeon cohorts. The exposures of interest are the operating surgeon's cumulative laparoscopic cholecystectomy experience and the Parkland grade of intraoperative difficulty. Electrosurgical activation patterns will be derived from synchronized recordings of the laparoscopic monitor and generator audio.

Procedure: Elective laparoscopic cholecystectomy

Interventions

Elective laparoscopic cholecystectomy PROCEDURE

Standard-of-care elective laparoscopic cholecystectomy. The study does not assign or modify the surgical procedure, operative technique, supervision, or clinical decisions. Investigators will observe electrosurgical activation patterns during two predefined operative segments using synchronized recording of the laparoscopic monitor and electrosurgical generator audio.

Elective Laparoscopic Cholecystectomy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective laparoscopic cholecystectomy in the regular operating program at the Department of Surgery, Division of Abdominal Surgery, University Hospital of Split. Consecutive eligible cases will be sampled within predefined surgeon cohorts. Male sex, age over 65 years, and thickened gallbladder wall are not exclusion criteria and will be recorded as potential covariates. An unexpectedly pronounced inflammatory or acute-like intraoperative finding does not itself exclude an otherwise elective case; difficulty will be captured using the Parkland grade.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

RECRUITING

Related Publications (3)

• Lombardi PM, Mazzola M, Veronesi V, Granieri S, Cioffi SPB, Baia M, Del Prete L, Bernasconi DP, Danelli P, Ferrari G. Learning curve of laparoscopic cholecystectomy: a risk-adjusted cumulative summation (RA-CUSUM) analysis of six general surgery residents. Surg Endosc. 2023 Oct;37(10):8133-8143. doi: 10.1007/s00464-023-10345-x. Epub 2023 Sep 8.

  PMID: 37684403 BACKGROUND

• Madni TD, Nakonezny PA, Barrios E, Imran JB, Clark AT, Taveras L, Cunningham HB, Christie A, Eastman AL, Minshall CT, Luk S, Minei JP, Phelan HA, Cripps MW. Prospective validation of the Parkland Grading Scale for Cholecystitis. Am J Surg. 2019 Jan;217(1):90-97. doi: 10.1016/j.amjsurg.2018.08.005. Epub 2018 Aug 21.

  PMID: 30190078 BACKGROUND

• Meeuwsen FC, Guedon ACP, Arkenbout EA, van der Elst M, Dankelman J, van den Dobbelsteen JJ. The Art of Electrosurgery: Trainees and Experts. Surg Innov. 2017 Aug;24(4):373-378. doi: 10.1177/1553350617705207. Epub 2017 Apr 24.

  PMID: 28438057 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Hyperthermia

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Ognjen Barcot, MD, PhD

  University Hospital of Split

  STUDY DIRECTOR

Central Study Contacts

Ognjen Barcot, MD, PhD

CONTACT

+385 21 556 691; ognjen.barcot@kbsplit.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 22, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 22, 2026

Record last verified: 2026-10

Locations

CR (1)