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Brachiocephalic arteriovenous fistulae: two different techniques of bloodless surgery and their effect on fistula stenosis.

Completed
Conditions
abnormal narrowing in bloodvessel
stenosis
10003184
10003216
Registration Number
NL-OMON46284
Lead Sponsor
HagaZiekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
104
Inclusion Criteria

- Mentally competent
- Written informed consent
- Age 18 years and older
- Indication for brachiocephalic AVF in HagaZiekenhuis
- Patient is able to complete the follow-up evaluation

Exclusion Criteria

Pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Duplex Ultrasonography ± 6 weeks postoperative: prevalence of anatomical or<br /><br>hemodynamic significant stenosis and the area of the stenosis in the arterial<br /><br>inflow, anastomosis or venous outflow region. - significant anatomical<br /><br>stenosis: a decrease >50% of vessel diameter compared to the immediately<br /><br>upstream or downstream 'normal' vessel - significant hemodynamically arterial<br /><br>inflow or venous outflow stenosis: Peak Systolic Velocity Ratio 2 or greater. -<br /><br>significant hemodynamically anastomotic stenosis: Peak Systolic Velocity Ratio<br /><br>3 or greater.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To compare preoperative factors between groups: - Demographic characteristics:<br /><br>age, gender, length, weight, BMI, smoking, use of drugs or alcohol, dominant<br /><br>arm, race. - Co-morbidity: indication AVF, Diabetes Mellitus, hypertension,<br /><br>hypercholesterolemy, peripheral arterial disease, etc. - Use of medication -<br /><br>Laboratory results. To compare operative factors between groups: - Duration of<br /><br>operation, duration of bloodless surgery, complications. To compare<br /><br>postoperative outcomes between groups: - Complications: death, hematoma,<br /><br>stenosis, occlusion, decrease of flow, bleeding, infection, pseudoaneurysm,<br /><br>accessory veins, steal syndrome, non-maturation, cardiac en pulmonary<br /><br>complications, reintervention. - Primary patency - Secondary patency</p><br>
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