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NCT Number: NCT05169073

Virtual Reality Training for Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Virtual Reality Bile Duct Injury Gallbladder Laparoscopy Medical Education

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Conventional training

Procedure

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

Primary outcomes

  1. Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon

    Time frame: On the day of surgery (within 12 hours)

    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.

Secondary outcomes

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

    Time frame: On the day of surgery (within 12 hours)

    For the global assessment of laparoscopic skills, the Global Operative Assessment of Laparoscopic Skills (GOALS) will be used. Evaluation will be performed by the resident (self-assessment).

  2. Critical View of Safety

    Time frame: Postoperative within 30 days (Video-Analysis)

    The "Sanford-Strasberg' Critical-view-of-safety (CVS)" is a method for judging the CVS objectively through intraoperative photographs. It evaluates the CVS captured by anterior and posterior ("doublet") views. The minimum score is 0, and the maximum is 6. The higher the score, the more satisfactory is the CVS. The "Sanford-Strasberg' CVS Score" is useful in evaluating the CVS in video records and the CVS has been recognized as an essential and effective security method to reduce the risk of bile duct injury.

  3. Time to critical view of safety

    Time frame: Postoperative within 30 days (Video-Analysis)

    Time required to achieve the CVS or i.e. until the clips are placed during the operation.

  4. Efficiency improvement

    Time frame: On the day of surgery (within 12 hours)

    Discrepancy between actual and planned operative time

  5. Self-confidence

    Time frame: On the day of surgery (within 12 hours)

    The self-confidence scale is a psychometrically valid tool to measure residents' self-confidence during surgical learning. Self-rating will be performed by selection of 6 items, each on a Likert scale ranging from 1 to 5. The maximum score attainable is 30 and the higher the score, the higher the self-confidence.

  6. Operative time

    Time frame: During surgery

    Time from incision to wound closure

  7. Intraoperative interventions by assisting surgeon

    Time frame: During surgery

    Any intervention necessary to guide to resident. I.e. whenever the assisting surgeon takes over the position of the operating surgeon.

Other outcomes

  1. Length of hospital stay

    Time frame: At the day of discharge

    Length of the total hospital stay (days)

  2. 90-day postoperative Complications

    Time frame: Until 90 days after surgery

    All postoperative deviations from the normal expected course graded according to the Accordion classification and the comprehensive complication index.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Kuemmerli, MD

CONTACT

[email protected]

+41616857548

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 23, 2021
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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