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Completed

NCT Number: NCT01632631

Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance

Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal.

Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance.

The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.

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Key information

Conditions

Infrarenal Aortic Aneurysm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sint - Maarten Hospital, Campus Rooienberg, Duffel, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-infrarenal aortic aneurysm suitable for endovascular exclusion

Exclusion criteria

  • Adult patients who do not have capacity to consent.
  • Previous stent-graft implanted in the abdominal aorta

Treatment and study plan

Primary outcomes

  1. Technical operative metrics

    Time frame: during EVAR procedure

    • C-arm positioning for proximal and distal landing zone
    • Fluoroscopy time
    • Number of angiograms
    • Amount of contrast

  2. Errors occurring during EVAR procedure (Imperial College Error Capture record)

    Time frame: during EVAR procedure

Secondary outcomes

  1. Subjective sense of realism of patient-specific rehearsal reported by team members

    Time frame: immediately after EVAR procedure

    Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire)

  2. Team satisfaction

    Time frame: immediately after EVAR procedure

    Team satisfaction Measurement: questionnaire

  3. Any deviation from initial treatment plan

    Time frame: immediately after EVAR procedure

  4. 30 day mortality and morbidity

    Time frame: within the first 30 days after surgery

  5. Technical and clinical success rate

    Time frame: immediately after EVAR procedure

    • Successful access to the arterial system using a remote site
    • Successful deployment of the endoluminal graft with secure proximal and distal fixation
    • Absence of either type I or III endoleak
    • Patent endoluminal graft without significant twist, kinks, or obstruction

  6. Initial clinical success

    Time frame: within the first 30 days after surgery

    o Successful deployment of the endovascular device at the intended location, without:

    • Death as a result of aneurysm-related treatment
    • Type I or III endoleak
    • Graft infection or thrombosis
    • Aneurysm expansion (diameter > 5mm)
    • Aneurysm rupture
    • Conversion to open repair
    • Graft dilatation (≥ 20% by diameter)
    • Graft migration
    • Failure of device integrity

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jul 3, 2012
Registry last updated
Dec 14, 2022

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.