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

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Infrarenal Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PROcedure rehearsal
PROcedure rehearsal performed before real EVAR procedure No intervention
No PROcedure rehearsal
no PROcedure rehearsal performed before real EVAR procedure No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632631

Contacts
Contact: Liesbeth Desender +32 9 332 63 88 Liesbeth.desender@ugent.be

Locations
Belgium
Sint - Maarten Hospital, Campus Rooienberg Recruiting
Duffel, Belgium, 2570
Contact: Johan Duchateau, MD         
Sub-Investigator: Johan Duchateau, MD         
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Liesbeth Desender, MD         
Principal Investigator: Frank Vermassen, Phd, MD         
Principal Investigator: Isabelle Van Herzeele, MD         
Principal Investigator: Liesbeth Desender, MD         
Switzerland
Zurich University Hospital Recruiting
Zurich, Switzerland, 8091
Contact: Mario Lachat, Phd, MD         
Sub-Investigator: Mario Lachat, Phd, MD         
Sub-Investigator: Zoran Rancic, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Liesbeth Desender Ghent University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01632631     History of Changes
Other Study ID Numbers: EC/2012/412
Study First Received: June 28, 2012
Last Updated: March 19, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
suitable for endovascular exclusion

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 16, 2014