Clinical trial NCT01632631: Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance
Official title: Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infrarenal Aortic Aneurysm
Keywords: suitable for endovascular exclusion
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Technical operative metrics
timeFrame: during EVAR procedure
measure: Errors occurring during EVAR procedure (Imperial College Error Capture record)
timeFrame: during EVAR procedure
Secondary outcomes:
measure: Subjective sense of realism of patient-specific rehearsal reported by team members
timeFrame: immediately after EVAR procedure
measure: Team satisfaction
timeFrame: immediately after EVAR procedure
measure: Any deviation from initial treatment plan
timeFrame: immediately after EVAR procedure
measure: 30 day mortality and morbidity
timeFrame: within the first 30 days after surgery
measure: Technical and clinical success rate
timeFrame: immediately after EVAR procedure
measure: Initial clinical success
timeFrame: within the first 30 days after surgery
Other outcomes:
Locations:
city: Duffel
country: Belgium
facility: Sint - Maarten Hospital, Campus Rooienberg
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Liesbeth Desender
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desender L, Van Herzeele I, Lachat M, Duchateau J, Bicknell C, Teijink J, Heyligers J, Vermassen F; PAVLOV Study Group. A Multicentre Trial of Patient specific Rehearsal Prior to EVAR: Impact on Procedural Planning and Team Performance. Eur J Vasc Endovasc Surg. 2017 Mar;53(3):354-361. doi: 10.1016/j.ejvs.2016.12.018. Epub 2017 Jan 20.