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Recruiting NCT05169073

Virtual Reality Training for Laparoscopic Cholecystectomy

No phase Interventional Virtual Reality Gallbladder Bile Duct Injury Medical Education

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality training, Conventional training.
Who it may be relevant to
Registry conditions: Virtual Reality, Gallbladder, Bile Duct Injury, Medical Education. Basic parameters: 22 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon [Time frame: On the day of surgery (within 12 hours)]
Secondary outcome measures (7)
  • Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident [Time frame: On the day of surgery (within 12 hours)]
  • Critical View of Safety [Time frame: Postoperative within 30 days (Video-Analysis)]
  • Time to critical view of safety [Time frame: Postoperative within 30 days (Video-Analysis)]
  • Efficiency improvement [Time frame: On the day of surgery (within 12 hours)]
  • Self-confidence [Time frame: On the day of surgery (within 12 hours)]
  • Operative time [Time frame: During surgery]
  • Intraoperative interventions by assisting surgeon [Time frame: During surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Prevention

Study locations

Switzerland · 1 center
  • University Centre for Gastrointesintal and Liver Disease — Basel

Publications

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

Identifiers

NCT: NCT05169073 · CU621

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗