Virtual Reality Training for Laparoscopic Cholecystectomy

Not Applicable

Recruiting

• Conditions: Medical Education; Gallbladder; Laparoscopy; Bile Duct Injury; Virtual Reality

• Registration Number: NCT05169073
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Cholecystectomy is one the most frequent laparoscopic procedures worldwide. It is a safe and effective operation but intraoperative bile duct injury remains a relevant complication with serious consequences for the patient. Most of the complications occur due to a lack of knowledge of the anatomy or misidentification of the cystic duct. Thus, the study of the anatomy is a cornerstone of a successful procedure and the preoperative magnetic resonance cholangiopancreatography (MRCP) is a way to preoperatively determine relevant structures to avoid intraoperative incidents.

This trial has been designed to assess the effect of preoperative virtual reality training based on MRCP on intraoperative performance and outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2021-12-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Referred for elective cholecystectomy for symptomatic cholecystolithiasis/chronic cholecystitis
• Early cholecystectomy after acute biliary pancreatitis
• Concomitant minor procedures (adhesiolysis, umbilical hernia repair, liver biopsy)
• Sufficient quality of MRCP

Exclusion Criteria

• American Society of Anaesthesiologists (ASA) classification ≥ 4
• Previous major open upper abdominal surgery
• Suspicion for concomitant biliary disease (e.g. Mirizzi-Syndrome)
• Robotic cholecystectomy
• Planned open procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon	On the day of surgery (within 12 hours)	For the global assessment of laparoscopic skills, the Global Operative Assessment of Laparoscopic Skills (GOALS) will be used. Evaluation will be performed by the attending surgeon. The GOALS is a 5 item rating scale and the items are scored using a 5-point Likert scale where "1" represents the lowest level of performance, and "5" is considered ideal performance. The total score for the global rating scale is the sum of the scores for each of the 5 items for a maximum total score of 25.

Secondary Outcome Measures

Name	Time	Method
Operative time	During surgery	Time from incision to wound closure
Self-confidence	On the day of surgery (within 12 hours)	The self-confidence scale is a psychometrically valid tool to measure residents' self-confidence during surgical learning. Self-rating will be performed by selection of 6 items, each on a Likert scale ranging from 1 to 5. The maximum score attainable is 30 and the higher the score, the higher the self-confidence.
Intraoperative interventions by assisting surgeon	During surgery	Any intervention necessary to guide to resident. I.e. whenever the assisting surgeon takes over the position of the operating surgeon.
Critical View of Safety	Postoperative within 30 days (Video-Analysis)	The "Sanford-Strasberg' Critical-view-of-safety (CVS)" is a method for judging the CVS objectively through intraoperative photographs. It evaluates the CVS captured by anterior and posterior ("doublet") views. The minimum score is 0, and the maximum is 6. The higher the score, the more satisfactory is the CVS. The "Sanford-Strasberg' CVS Score" is useful in evaluating the CVS in video records and the CVS has been recognized as an essential and effective security method to reduce the risk of bile duct injury.
Efficiency improvement	On the day of surgery (within 12 hours)	Discrepancy between actual and planned operative time
Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident	On the day of surgery (within 12 hours)	For the global assessment of laparoscopic skills, the Global Operative Assessment of Laparoscopic Skills (GOALS) will be used. Evaluation will be performed by the resident (self-assessment).
Time to critical view of safety	Postoperative within 30 days (Video-Analysis)	Time required to achieve the CVS or i.e. until the clips are placed during the operation.

Trial Locations

Locations (1)

University Centre for Gastrointesintal and Liver Disease; 🇨🇭 Basel, Switzerland