One-year results of end vein-to-side artery versus side vein-to-side artery with distal vein ligation radiocephalic arteriovenous fistula: A randomized, single-blind clinical trial.

Not Applicable

Recruiting

• Conditions: End stage renal disease.; End stage renal disease; N18.6

• Registration Number: IRCT20210507051204N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 May 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The patient is referred for the first time by a nephrologist for of permanent hemodialysis access implantation .
Clinical examination of both upper limbs should confirm all of the following criteria: 1) Presence of the cephalic vein in distal third of forearm 2) Presence of the radial pulse 3) Presence of the ulnar pulse 4) Positive Allen's test 5) Cephalic vein and radial artery in distal third of forearm are not more than 2 cm apart.
Preoperative arteriovenous mapping by Doppler ultrasound confirms all of the following criteria: 1) Patent cephalic vein with a minimum diameter of 2.5 mm in distal third of forearm, with no stenosis and a minimum continuity of 15 cm 2) Patent radial artery, with a minimum diameter of 2 mm in distal third of forearm, free of stenosis and major calcifications 3) Patent ulnar artery, free of stenosis and major calcifications 4) Positive Allen's test as confirmed by retrograde flow test (patent palm arch) 5) Cephalic vein and radial artery in distal third of forearm are not more than 2 cm apart.
Patient's informed consent to participate in the study.

Exclusion Criteria

Patients under guardianship
Evidence of concomitant central venous obstruction at the time of referral

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency. Timepoint: 6 months. Method of measurement: Clinical examination and duplex ultrasonography.

Secondary Outcome Measures

Name	Time	Method
Primary patency. Timepoint: 12 months. Method of measurement: Clinical examination and duplex ultrasonography.;Secondary patency. Timepoint: 6 and 12 month. Method of measurement: Clinical examination and duplex ultrasonography.;Maturation of AVF. Timepoint: 3 and 6 months. Method of measurement: Duplex ultrasonography.;Incidence of complications. Timepoint: 1 year. Method of measurement: Checklist, clinical examination and duplex ultrasonography.;1-year reintervention rate. Timepoint: 12 months. Method of measurement: Questionnaire and medical records of patients.;1-year cumulative patency. Timepoint: 12 months. Method of measurement: Clinical examination, duplex ultrasonography and medical records of patients.