Overview

This trial is active, not recruiting.

Condition infrarenal aortic aneurysm
Sponsor University Hospital, Ghent
Start date February 2013
End date June 2014
Trial size 100 participants
Trial identifier NCT01632631, EC/2012/412

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
PROcedure rehearsal performed before real EVAR procedure No intervention
no PROcedure rehearsal performed before real EVAR procedure No intervention

Primary Outcomes

Measure
Technical operative metrics
time frame: during EVAR procedure
Errors occurring during EVAR procedure (Imperial College Error Capture record)
time frame: during EVAR procedure

Secondary Outcomes

Measure
Subjective sense of realism of patient-specific rehearsal reported by team members
time frame: immediately after EVAR procedure
Team satisfaction
time frame: immediately after EVAR procedure
Any deviation from initial treatment plan
time frame: immediately after EVAR procedure
30 day mortality and morbidity
time frame: within the first 30 days after surgery
Technical and clinical success rate
time frame: immediately after EVAR procedure
Initial clinical success
time frame: within the first 30 days after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.
Principal investigator Liesbeth Desender
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.