An interventional study of Double vein cuffed ePTFE graft both at the inflow and outflow ends and single vein cuffed eTFE graft both at the inflow and outflow ends in End Stage Renal Disease, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality
End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. A proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.ePTFE grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. The commonest cause of PTFE graft failure is intimal hyperplasia (IH) at the venous anastomoses. our study aims to evaluate the influence of double cuffed ePTFE grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy.
this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality
Exclusion Criteria:
Double vein cuff PTFE graft both at the inflow and outflow ends
Procedure: Double vein cuffed ePTFE graft both at the inflow and outflow ends
Single vein cuffed PTFE graft at the outflow end
Procedure: single vein cuffed eTFE graft both at the inflow and outflow ends
PTFE graft without vein cuff will be used
Procedure: ePTFE graft without any cuff
Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around both ends of PTFE Graft
Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around the venous end of PTFE Graft
anastmosis between arterial and venous side usinf non cuffed ePTFE graft
primary patency
comparing primary patency between the double cuffed, single cuffed and non cuffed ePTFE graft primary patency means how long will the graft be patent after the first intervention
Time frame: 2 years for each patient after the operation
secondary patency
comparing secondary patency between the double cuffed, single cuffed and non cuffed ePTFE graft secondary patency means how long will the graft be patent after thormobectomy to a thrombosed graft
Time frame: 2 years after restoration of patency
Plan to share: No
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Mansoura University