The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Virtual Reality
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon
Time Frame: 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 Outcomes
- Operative time(During surgery)
- Self-confidence(On the day of surgery (within 12 hours))
- Intraoperative interventions by assisting surgeon(During surgery)
- Critical View of Safety(Postoperative within 30 days (Video-Analysis))
- Efficiency improvement(On the day of surgery (within 12 hours))
- Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident(On the day of surgery (within 12 hours))
- Time to critical view of safety(Postoperative within 30 days (Video-Analysis))