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AzTrials

Virtual RealityNCT05169073

Virtual Reality Training for Laparoscopic Cholecystectomy

A study testing Virtual Reality training and Conventional training in people with Virtual Reality and Gallbladder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 45 years
Conditions the study is for
Virtual Reality, Gallbladder, Bile Duct Injury
What is being tested?
Virtual Reality training and Conventional training
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
1 Nov 2021to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christoph Kuemmerli, MD contact

+41616857548

christoph.kuemmerli@clarunis.ch

Switzerland1 site, 1 recruiting

  • University Centre for Gastrointesintal and Liver Disease

    Basel, 4058

    Christoph Kuemmerli, MD, +41616857548, christoph.kuemmerli@clarunis.ch

    Sebastian Staubli, MD, +41616858585, sebastian.staubli@clarunis.ch

    Recruiting

Other trials in Switzerland

About this study

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

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.

Being tested
Virtual Reality training, Conventional training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality trainingProcedure or surgery

    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 trainingProcedure or surgery

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

Study groups in NCT05169073
Study groupRoleWhat they receive
Virtual Reality MRCPExperimentalThe 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.
Receives: Procedure: Virtual Reality training
Conventional MRCPActive comparatorControls will have regular access to the conventional MRCP images.
Receives: Procedure: Conventional training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: On the day of surgery (within 12 hours)

Secondary outcomes (7)

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

    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).

    Measured: On the day of surgery (within 12 hours)

  2. Critical View of Safety

    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.

    Measured: Postoperative within 30 days (Video-Analysis)

  3. Time to critical view of safety

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

    Measured: Postoperative within 30 days (Video-Analysis)

  4. Efficiency improvement

    Discrepancy between actual and planned operative time

    Measured: On the day of surgery (within 12 hours)

  5. Self-confidence

    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.

    Measured: On the day of surgery (within 12 hours)

  6. Operative time

    Time from incision to wound closure

    Measured: During surgery

  7. Intraoperative interventions by assisting surgeon

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

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start1 Nov 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
The order in which the operations will be performed by each resident is random.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169073
Sponsor's protocol ID
CU621
Status last verified
Apr 2025
First submitted
7 Dec 2021
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 23660044

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality training and Conventional training in people with Virtual Reality and Gallbladder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christoph Kuemmerli, MD (+41616857548, christoph.kuemmerli@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon (time frame: On the day of surgery (within 12 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169073, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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