Percutaneous access in Endovascular Repair versus Ope

Completed

Conditions: Surgical site infections in aneurysm repair
10003184
10002363

Registration Number: NL-OMON41463

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 137

Inclusion Criteria

Patients must be physically and mentally capable of giving consent for randomised femoral access and data storage,
in the possession of an aneurysm of the abdominal aorta with a diameter of at least 55 millimetres (or growth of 5 millimetres or more in half a years* time),
suitable for bifurcated endovascular repair through two femoral access sites, without additional access needed.

Exclusion Criteria

Patients with extreme atherosclerosis (more than half (1/2) of the circumference of the CFA)
Previous common femoral artery surgery.
Patients treated with an aorto-monoiliacal device implanted, followed by a femorofemoral cross-over.
Patients in need for more than two femoral accesses (brachial or carotid).
Patients treated with a Nellie device (Endologics)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the main study endpoint is the risk reduction of the number of surgical site<br /><br>infections (SSI*s) after the use of percutaneous access compared to a surgical<br /><br>cut-down for an EVAR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is 1 year postoperatively. VAS scores and bacterial<br /><br>contamination in wound infections will be evaluated.Cultures and biopsies are<br /><br>used.<br /><br><br /><br>A correlation is sought between the cultures harvested from the nose and the<br /><br>perineum.<br /><br><br /><br>Also cost-effectiveness is questioned in case of a significant difference<br /><br>between the SSI-incidences.</p><br>