Virtual Reality Training for Laparoscopic Cholecystectomy

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169073
• Other study ID #: CU621
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Christoph Kuemmerli, MD
• Phone: +41616857548
• Email: christoph.kuemmerli[@]clarunis.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Injury
• Gallbladder
• Laparoscopy
• Medical Education
• Virtual Reality

Intervention

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).
• Conventional training
In the conventional study arm, the participants will view the preoperative MRCP.

Locations

Country	Name	City	State
Switzerland	University Centre for Gastrointesintal and Liver Disease	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University of Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Length of the total hospital stay (days)	At the day of discharge
Other	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Efficiency improvement	Discrepancy between actual and planned operative time	On the day of surgery (within 12 hours)
Secondary	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)
Secondary	Operative time	Time from incision to wound closure	During surgery
Secondary	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