Virtual Reality Training for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study

Conditions
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Virtual Reality, Gallbladder, Bile Duct Injury, Medical Education, Laparoscopy

Intervention / Treatment
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* Procedure: Virtual Reality training
* Procedure: Conventional training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The order in which the operations will be performed by each resident is random.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality MRCP<br>The MRCP images will be transferred into a 3D VR rendering software (Specto VR TM) for each patient. Residents will have the opportunity to use the virtual reality environment the day before surgery until a sufficient understanding of the anatomy is achieved. | Procedure: Virtual Reality training<br>* In the Virtual Reality (VR) study arm, a VR software (Specto VRTM, version 4.0, Diffuse Ltd, Heimberg, Switzerland) will be used to display volumetric MRCP data using a tethered head-mounted display (HMD) prior to the operation. Specto uses volume rendering at 180 frames/sec to visualize the medical data in an immersive fashion in the VR environment and allows for viewing of the 3D reconstructed 3D imaging with 360° free movement. Each participant will perform a procedure with VR training and one with conventional preparation (MRCP).<br>|
| Active Comparator: Conventional MRCP<br>Controls will have regular access to the conventional MRCP images. | Procedure: Conventional training<br>* In the conventional study arm, the participants will view the preoperative MRCP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon | 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. | On the day of surgery (within 12 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident | 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). | On the day of surgery (within 12 hours) | 
| Critical View of Safety | 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. | Postoperative within 30 days (Video-Analysis) | 
| Time to critical view of safety | Time required to achieve the CVS or i.e. until the clips are placed during the operation. | Postoperative within 30 days (Video-Analysis) | 
| Efficiency improvement | Discrepancy between actual and planned operative time | On the day of surgery (within 12 hours) | 
| Self-confidence | 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. | On the day of surgery (within 12 hours) | 
| Operative time | Time from incision to wound closure | During surgery | 
| Intraoperative interventions by assisting surgeon | Any intervention necessary to guide to resident. I.e. whenever the assisting surgeon takes over the position of the operating surgeon. | During surgery |