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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

laparoscopyVirtual RealityGallbladderBile Duct InjuryMedical Education

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether using virtual reality (VR) training before gallbladder removal surgery (laparoscopic cholecystectomy) helps surgeons perform the operation more safely — potentially reducing complications like bile duct injury. You may be eligible if: - You are 22–45 years old - You are scheduled for elective gallbladder removal for gallstones or chronic gallbladder inflammation - Your surgery is being done after acute biliary pancreatitis, or minor procedures are being added - You have acceptable imaging quality (MRCP) You may NOT be eligible if: - Your overall health risk is very high (ASA classification ≥4) - You have had major open abdominal surgery in the upper abdomen before - There is suspicion of another bile duct problem (e.g., Mirizzi Syndrome) - Your surgery will be robotic or planned as open surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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