Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | December 2014 |
The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
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.
technique is associated with more complications, fistula failures, surgical cost and
surgical time.
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.
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.
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.
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