RecruitingNot ApplicableNCT05169073

Virtual Reality Training for Laparoscopic Cholecystectomy

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

20 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 45 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Interventions

PROCEDUREVirtual 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).

PROCEDUREConventional training

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


Locations(1)

University Centre for Gastrointesintal and Liver Disease

Basel, Switzerland

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NCT05169073


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