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

Infrarenal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632631
• Other study ID #: EC/2012/412
• Status: Completed
• Start date: September 2012
• Est. completion date: August 2016

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Infrarenal Aortic Aneurysm

Locations

Country	Name	City	State
Belgium	Sint - Maarten Hospital, Campus Rooienberg	Duffel
Belgium	Ghent University Hospital	Ghent
Switzerland	Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical operative metrics	C-arm positioning for proximal and distal landing zone; Fluoroscopy time; Number of angiograms; Amount of contrast	during EVAR procedure
Primary	Errors occurring during EVAR procedure (Imperial College Error Capture record)		during EVAR procedure
Secondary	Subjective sense of realism of patient-specific rehearsal reported by team members	Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire)	immediately after EVAR procedure
Secondary	Team satisfaction	Team satisfaction Measurement: questionnaire	immediately after EVAR procedure
Secondary	Any deviation from initial treatment plan		immediately after EVAR procedure
Secondary	30 day mortality and morbidity		within the first 30 days after surgery
Secondary	Technical and clinical success rate	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	immediately after EVAR procedure
Secondary	Initial clinical success	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	within the first 30 days after surgery