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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46284

Enrollment

104

Registered

2015-12-15

Start date

2016-04-28

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abnormal narrowing in bloodvessel stenosis

Interventions

Intervention: the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery. Comparator: the use of vascular clamps to obtain a bloodless field during arteriovenous fistul

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Pregnancy

Design outcomes

Primary

Measure	Time frame
Duplex Ultrasonography ± 6 weeks postoperative: prevalence of anatomical or hemodynamic significant stenosis and the area of the stenosis in the arterial inflow, anastomosis or venous outflow region. - significant anatomical stenosis: a decrease >50% of vessel diameter compared to the immediately upstream or downstream 'normal' vessel - significant hemodynamically arterial inflow or venous outflow stenosis: Peak Systolic Velocity Ratio 2 or greater. - significant hemodynamically anastomotic stenosis: Peak Systolic Velocity Ratio 3 or greater.	—

Measure

Time frame

Duplex Ultrasonography ± 6 weeks postoperative: prevalence of anatomical or hemodynamic significant stenosis and the area of the stenosis in the arterial inflow, anastomosis or venous outflow region. - significant anatomical stenosis: a decrease >50% of vessel diameter compared to the immediately upstream or downstream 'normal' vessel - significant hemodynamically arterial inflow or venous outflow stenosis: Peak Systolic Velocity Ratio 2 or greater. - significant hemodynamically anastomotic stenosis: Peak Systolic Velocity Ratio 3 or greater.

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Secondary

Measure	Time frame
To compare preoperative factors between groups: - Demographic characteristics: age, gender, length, weight, BMI, smoking, use of drugs or alcohol, dominant arm, race. - Co-morbidity: indication AVF, Diabetes Mellitus, hypertension, hypercholesterolemy, peripheral arterial disease, etc. - Use of medication - Laboratory results. To compare operative factors between groups: - Duration of operation, duration of bloodless surgery, complications. To compare postoperative outcomes between groups: - Complications: death, hematoma, stenosis, occlusion, decrease of flow, bleeding, infection, pseudoaneurysm, accessory veins, steal syndrome, non-maturation, cardiac en pulmonary complications, reintervention. - Primary patency - Secondary patency	—

Measure

Time frame

To compare preoperative factors between groups: - Demographic characteristics: age, gender, length, weight, BMI, smoking, use of drugs or alcohol, dominant arm, race. - Co-morbidity: indication AVF, Diabetes Mellitus, hypertension, hypercholesterolemy, peripheral arterial disease, etc. - Use of medication - Laboratory results. To compare operative factors between groups: - Duration of operation, duration of bloodless surgery, complications. To compare postoperative outcomes between groups: - Complications: death, hematoma, stenosis, occlusion, decrease of flow, bleeding, infection, pseudoaneurysm, accessory veins, steal syndrome, non-maturation, cardiac en pulmonary complications, reintervention. - Primary patency - Secondary patency

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)