Trial Comparing One-stage With Two-stage Basilic Vein Transposition
- Conditions
- Brachiobasilic Arteriovenous Fistula
- Interventions
- Procedure: Transposition of the basilic vein and anastomosis with the brachial vein
- Registration Number
- NCT01274117
- Lead Sponsor
- University of Patras
- Brief Summary
Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and clear the blood from wastes, in patients whose kidneys are destroyed and cannot provide this function. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates movement (transposition) during surgery to a less deep and lateral path before it is joined to the artery, in order to be used. A single study has shown that surgery performed in two parts (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure altogether.
The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the vein will be relocated outside the main wound, a method that is widely accepted as being better.
- Detailed Description
Arteriovenous fistulas (AVFs) are made by anastomosing a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and perform hemodialysis in patients with renal failure. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates transposition during surgery to a less deep and lateral subcutaneous plane before the anastomosis with the artery, in order to be used. A single study has shown that surgery performed in two stages (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure in one stage.
The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the basilic vein will be relocated outside the main wound, a method that is widely accepted as being better.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- chronic renal failure on hemodialysis
- chronic renal failure with anticipated hemodialysis
- Patient unwillingness, not consenting
- Cephalic vein options
- Basilic vein less than 2.5 mm
- Basilic vein with intrinsic lesions, unsuitable for use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One-stage transposition of the basilic vein Transposition of the basilic vein and anastomosis with the brachial vein One-stage transposition of the basilic vein Two-stage transposition of the basilic vein Transposition of the basilic vein and anastomosis with the brachial vein Two-stage transposition of the basilic vein
- Primary Outcome Measures
Name Time Method Long term primary, primary assisted and secondary patency 1-3 years Long term primary, primary assisted and secondary patency
Maturation rate 6-10 weeks Usage of the AVF (or clearance in case of pre-hemodialysis)
- Secondary Outcome Measures
Name Time Method Complication rate 1-3 years Hematoma, steal syndrome, venous hypertension
Basilic vein size 4 weeks Basilic vein size on ultrasound
Trial Locations
- Locations (1)
University Hospital of Patras
🇬🇷Patras, Achaia, Greece