Virtual Reality Training for Laparoscopic Cholecystectomy

NCT05169073 | Recruiting

• 1 other identifier: CU621
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident

  On the day of surgery (within 12 hours)

• Critical View of Safety

  Postoperative within 30 days (Video-Analysis)

• Time to critical view of safety

  Postoperative within 30 days (Video-Analysis)

• Efficiency improvement

  On the day of surgery (within 12 hours)

• Self-confidence

  On the day of surgery (within 12 hours)

Other Outcomes (2)

• Length of hospital stay

  At the day of discharge

• 90-day postoperative Complications

  Until 90 days after surgery

Study Arms (2)

Virtual Reality MRCP

EXPERIMENTAL

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

Conventional MRCP

ACTIVE COMPARATOR

Controls will have regular access to the conventional MRCP images.

Procedure: Conventional training

Interventions

Virtual Reality training PROCEDURE

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).

Virtual Reality MRCP

Conventional training PROCEDURE

In the conventional study arm, the participants will view the preoperative MRCP.

Conventional MRCP

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator

Study Sites (1)

University Centre for Gastrointesintal and Liver Disease

Basel, 4058, Switzerland

RECRUITING

Related Publications (4)

• Nassar AHM, Ashkar KA, Mohamed AY, Hafiz AA. Is laparoscopic cholecystectomy possible without video technology? Minimally Invasive Therapy. 1995; 4:2 63-65

  BACKGROUND

• 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.

  PMID: 15972181 BACKGROUND

• 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.

  PMID: 24440064 BACKGROUND

• 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.

  PMID: 23660044 BACKGROUND

Study Officials

• Sebastian Staubli, MD

  Clarunis - University Center for Gastrointestinal and Liver Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Kuemmerli, MD

CONTACT

+41616857548; christoph.kuemmerli@clarunis.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and analyst
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The order in which the operations will be performed by each resident is random.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 23, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)