Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Not Applicable

Terminated

• Conditions: Arteriovenous Fistula Complications and Failure
• Interventions: Device: Clipped anastomosis; Procedure: Handsewn anastomosis

• Registration Number: NCT01669850
• Lead Sponsor: Gundersen Lutheran Medical Foundation

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clipped anastomosis	Clipped anastomosis	A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.
Handsewn anastomosis	Handsewn anastomosis	A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gundersen Lutheran Health System; 🇺🇸 La Crosse, Wisconsin, United States