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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01632631
First received: June 28, 2012
Last updated: March 19, 2013
Last verified: February 2013

June 28, 2012
March 19, 2013
February 2013
September 2013   (final data collection date for primary outcome measure)
  • Technical operative metrics [ Time Frame: during EVAR procedure ] [ Designated as safety issue: Yes ]
    • C-arm positioning for proximal and distal landing zone
    • Fluoroscopy time
    • Number of angiograms
    • Amount of contrast
  • Errors occurring during EVAR procedure (Imperial College Error Capture record) [ Time Frame: during EVAR procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01632631 on ClinicalTrials.gov Archive Site
  • Subjective sense of realism of patient-specific rehearsal reported by team members [ Time Frame: immediately after EVAR procedure ] [ Designated as safety issue: No ]
    Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire)
  • Team satisfaction [ Time Frame: immediately after EVAR procedure ] [ Designated as safety issue: No ]
    Team satisfaction Measurement: questionnaire
  • Any deviation from initial treatment plan [ Time Frame: immediately after EVAR procedure ] [ Designated as safety issue: No ]
  • 30 day mortality and morbidity [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Technical and clinical success rate [ Time Frame: immediately after EVAR procedure ] [ Designated as safety issue: Yes ]
    • 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
  • Initial clinical success [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]

    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
Same as current
Not Provided
Not Provided
 
Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance
Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with an infrarenal aortic aneurysm suitable for endovascular exclusion. The suitability for endovascular repair is based upon the physician's decision.

Infrarenal Aortic Aneurysm
Not Provided
  • PROcedure rehearsal
    PROcedure rehearsal performed before real EVAR procedure No intervention
  • No PROcedure rehearsal
    no PROcedure rehearsal performed before real EVAR procedure No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Liesbeth Desender +32 9 332 63 88 Liesbeth.desender@ugent.be
Belgium,   Switzerland
 
NCT01632631
EC/2012/412
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Liesbeth Desender Ghent University Hospital
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP