Clinical Trial: Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Gundersen Lutheran Medical Foundation

Current Primary Outcome: Patency rates [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Surgical complications [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Gundersen Lutheran Medical Foundation

Dates:
Date Received: August 16, 2012
Date Started: August 2012
Date Completion:
Last Updated: September 4, 2015
Last Verified: September 2015