Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Gundersen Lutheran Medical Foundation

Status: Terminated

Conditions: Arteriovenous Fistula Complications and Failure

Treatments: Procedure: Handsewn anastomosis; Device: Clipped anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01669850

2-12-07-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Clipped anastomosis

Experimental group

Description:

A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.

Treatment:

Device: Clipped anastomosis

Handsewn anastomosis

Active Comparator group

Description:

A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.

Treatment:

Procedure: Handsewn anastomosis