Virtual Reality Training for Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Medical Education; Virtual Reality; Laparoscopy; Bile Duct Injury; Gallbladder
• Intervention / Treatment: Procedure: Virtual Reality training; Procedure: Conventional training

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Kuemmerli, MD; Phone Number: +41616857548; Email: christoph.kuemmerli@clarunis.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4058
    • Recruiting
    • University Centre for Gastrointesintal and Liver Disease
    • Contact: Christoph Kuemmerli, MD; Phone Number: +41616857548; Email: christoph.kuemmerli@clarunis.ch
    • Contact: Sebastian Staubli, MD; Phone Number: +41616858585; Email: sebastian.staubli@clarunis.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality MRCP; 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; 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).
Active Comparator: Conventional MRCP; Controls will have regular access to the conventional MRCP images.	Procedure: Conventional training; In the conventional study arm, the participants will view the preoperative MRCP.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of the total hospital stay (days)	At the day of discharge
90-day postoperative Complications	All postoperative deviations from the normal expected course graded according to the Accordion classification and the comprehensive complication index.	Until 90 days after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Basel
• Investigators: Principal Investigator: Sebastian Staubli, MD, Clarunis - University Center for Gastrointestinal and Liver Diseases

Publications and helpful links

General Publications

• Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004.
• Nassar AHM, Ashkar KA, Mohamed AY, Hafiz AA. Is laparoscopic cholecystectomy possible without video technology? Minimally Invasive Therapy. 1995; 4:2 63-65
• Sanford DE, Strasberg SM. A simple effective method for generation of a permanent record of the Critical View of Safety during laparoscopic cholecystectomy by intraoperative "doublet" photography. J Am Coll Surg. 2014 Feb;218(2):170-8. doi: 10.1016/j.jamcollsurg.2013.11.003. Epub 2013 Nov 9.
• Geoffrion R, Lee T, Singer J. Validating a self-confidence scale for surgical trainees. J Obstet Gynaecol Can. 2013 Apr;35(4):355-361. doi: 10.1016/S1701-2163(15)30964-6.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CU621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No