Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas

Conditions
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Arteriovenous Fistula Complications and Failure

Intervention / Treatment
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* Device: Clipped anastomosis
* Procedure: Handsewn anastomosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clipped anastomosis<br>A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation. | Device: Clipped anastomosis<br>* The vascular clip devise will be used to complete the anastomosis during fistula creation.<br>* Other names: Anastoclip (Le Maitre);|
| Active Comparator: Handsewn anastomosis<br>A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation. | Procedure: Handsewn anastomosis<br>* a handsewn anastomosis technique will be used during fistula creation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rates | 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. | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia. | 2 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Arteriovenous fistula, Surgical anastomosis, Complications, Patency, Dialysis access