Clinical Trials Directory

Trials / Terminated

TerminatedNCT01274117

Trial Comparing One-stage With Two-stage Basilic Vein Transposition

Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
University of Patras · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETransposition of the basilic vein and anastomosis with the brachial veinOne-stage vs two-stage transposition of the basilic vein

Timeline

Start date
2010-12-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2011-01-11
Last updated
2017-10-25

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT01274117. Inclusion in this directory is not an endorsement.