Arterio-venous Fistula
Conditions
Brief summary
Randomized controlled study to compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B). The study population will be patients referred to the Vascular surgery department for the creation of Hemodialysis access. Patients will be advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min. primary outcome: Functional Maturation of Arterio-venous Fistula \[ Time Frame: Six Months\] Ready fistula for cannulation, vein length at least 10 cm, diameter more than 6 mm, depth not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours.
Detailed description
Introduction Aim of the work To compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B). Patients and the method Study location: We will submit the study protocol for approval by Kafr ElSheikh medical research ethics committee, faculty of medicine, Kafr ElSheikh University. Study design: Randomized controlled study will be conducted in the department of vascular surgery in Kafr El Sheikh. Time of study: We started in march 2022. Study population: The study population will be patients referred to the Vascular surgery department for the creation of Hemodialysis access. Patients will be advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min. The number of patients: This study will be done on 150 cases, 75 cases in group A (anchor technique) and another 75 in group B (parachute technique).
Interventions
OTHERsuturing technique in arteriovenous fistula creation for hemodialysis
End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eighteen years of age or older. * Need for AVF creation for vascular access for planned hemodialysis (within one year), Including distal - Radio-cephalic, proximal brachio-cephalic configurations. * Vein mapping studies completed 2.5-3 mm minimum vein diameter on mapping.
Exclusion criteria
* Ipsilateral proximal venous and arterial occlusion or stenosis * systemic or local infection at the site planned for AVF creation. * Anticipated inability to keep 30-day post-operative follow-up appointment. * Revision AVF, Synthetic graft AVF, or lower limb AVF. * Patients with absent distal pulses and chronic ischemia of the upper limb. * Recent cannulation of puncture of the vein within two weeks before its use in AVF creation. * Vasculitis (collagen diseases)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Maturation of Arterio-venous Fistula | 6 months | The suitability of an AVF for successful cannulation for dialysis, ascertained by duplex ultrasound study by measuring vein length at least 10 cm, diameter more than 6 mm, depth for skin not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate and failure of maturation | Six Months | Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site. |
Countries
Egypt
Outcome results
None listed