A global assessment tool for evaluation of intraoperative laparoscopic skills.
Melina C Vassiliou, Liane S Feldman, Christopher G Andrew...
https://pubmed.ncbi.nlm.nih.gov/15972181Actively Recruiting
Phase Not Applicable
Age: 22Years - 45Years
All Genders
ID05169073
The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study
Led by University Hospital, Basel, Switzerland · Updated on 2025-04-15
20
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
U
University of Basel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of preoperative virtual reality training based on magnetic resonance cholangiopancreatography (MRCP) on surgical performance and outcomes during laparoscopic cholecystectomy. This procedure is commonly performed worldwide and is generally safe, but bile duct injury remains a serious complication often caused by misidentification of anatomy. The study aims to improve understanding of relevant anatomical structures to reduce intraoperative incidents. Participants are randomly assigned to one of two groups: the experimental group receives virtual reality training using 3D MRCP images rendered in an immersive VR environment the day before surgery, while the control group accesses conventional MRCP images. Each participant will experience both VR training and conventional preparation. The VR software allows free movement and detailed viewing of 3D reconstructed images to enhance anatomical understanding. During the study, surgical skills are assessed on the day of surgery using the Global Assessment of Laparoscopic Skills (GOALS) score by both assisting surgeons and residents. Additional measures include evaluation of the critical view of safety through video analysis within 30 days postoperatively, operative time, efficiency improvements, self-confidence, and intraoperative interventions. The study monitors performance closely around the time of surgery to assess the effect of VR training on surgical outcomes.
CONDITIONS
Brief Title
Virtual Reality Training for Laparoscopic Cholecystectomy
Who Can Participate
Age: 22Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- Referred for elective cholecystectomy for symptomatic cholecystolithiasis or chronic cholecystitis
- Early cholecystectomy after acute biliary pancreatitis
- Undergoing concomitant minor procedures such as adhesiolysis, umbilical hernia repair, or liver biopsy
- Sufficient quality of preoperative MRCP images
- Age between 22 and 45 years
You will not qualify if you...
- American Society of Anaesthesiologists (ASA) classification of 4 or higher
- Previous major open upper abdominal surgery
- Suspicion of additional biliary diseases like Mirizzi syndrome
- Planned robotic cholecystectomy
- Planned open surgical procedures instead of laparoscopic
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Training
Duration - The day before surgery
Participants receive training using either virtual reality 3D MRCP rendering or conventional MRCP images prior to surgery to prepare for laparoscopic cholecystectomy.
1 training session (in-person)
Surgery
Duration - Day of surgery
Participants undergo laparoscopic cholecystectomy with assessment of surgical performance on the day of surgery.
1 surgical procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 30 days post-surgery
Participants are monitored for surgical outcomes including video analysis of critical view of safety within 30 days after surgery.
Follow-up visits as needed within 30 days
Trial Site Locations
Total: 1 location
1
University Centre for Gastrointesintal and Liver Disease
Basel, Switzerland, 4058
Actively Recruiting
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Research Team
C
Christoph Kuemmerli, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
A simple effective method for generation of a permanent record of the Critical View of Safety during laparoscopic cholecystectomy by intraoperative "doublet" photography.
Dominic E Sanford, Steven M Strasberg
https://pubmed.ncbi.nlm.nih.gov/24440064Validating a self-confidence scale for surgical trainees.
Roxana Geoffrion, Terry Lee, Joel Singer
https://pubmed.ncbi.nlm.nih.gov/23660044