Virtual Reality Training for Laparoscopic Cholecystectomy

NCT ID: NCT05169073

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality training

Intervention Type: 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).

Conventional MRCP

Controls will have regular access to the conventional MRCP images.

Group Type: ACTIVE_COMPARATOR

Conventional training

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: PROCEDURE

Conventional training

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Staubli, MD

Role: PRINCIPAL_INVESTIGATOR

Clarunis - University Center for Gastrointestinal and Liver Diseases

Locations

University Centre for Gastrointesintal and Liver Disease

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Christoph Kuemmerli, MD

Role: CONTACT

christoph.kuemmerli@clarunis.ch

+41616857548

Facility Contacts

Christoph Kuemmerli, MD

Role: primary

christoph.kuemmerli@clarunis.ch

+41616857548

Sebastian Staubli, MD

Role: backup

sebastian.staubli@clarunis.ch

+41616858585

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 15972181 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24440064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23660044 (View on PubMed)

Other Identifiers

CU621

Identifier Type: -

Identifier Source: org_study_id