Arteriovenous Fistula Complications and Failure
Conditions
Keywords
Chronic kidney disease, Arteriovenous fistula, Surgical anastomosis, Complications, Patency, Dialysis access
Brief summary
The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.
Detailed description
End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.
Interventions
DEVICEClipped anastomosis
The vascular clip devise will be used to complete the anastomosis during fistula creation.
PROCEDUREHandsewn anastomosis
a handsewn anastomosis technique will be used during fistula creation.
Sponsors
Gundersen Lutheran Health System
Gundersen Lutheran Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Need for AVF creation for vascular access for planned hemodialysis (within 1 year). * The planned AVF site must be naïve of prior AVF creations. * Vein mapping studies completed * 2.5 - 3mm minimum vein diameter on mapping
Exclusion criteria
* Less than 18 years of age. * Inability to provide consent. * Previous failed AVFs in both arms. * Contraindications to AVF creation: * ipsilateral proximal venous and arterial occlusion or stenosis * systemic or local infection * too ill to operate * Anticipated inability to keep 30-day postoperative follow-up appointment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency rates | 2 years postoperative | Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | 2 years postoperative | Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost | 1 year postoperative | Cost for the vascular clip device will be compared to cost of the handsewn technique. |
Countries
United States
Outcome results
None listed