NCT01669850

Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Gundersen Lutheran Medical Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arteriovenous Fistula Complications and Failure

Interventions

Type	Name	Description
DEVICE	Clipped anastomosis	The vascular clip devise will be used to complete the anastomosis during fistula creation.
PROCEDURE	Handsewn anastomosis	a handsewn anastomosis technique will be used during fistula creation.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-08-21
• Last updated: 2015-09-07

Locations

1 site across 1 country: United States