Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Arteriovenous Fistula Complications and Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01669850
• Other study ID #: 2-12-07-002
• Status: Terminated
• Phase: N/A
• First received: August 16, 2012
• Last updated: September 4, 2015
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Gundersen Lutheran Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Gundersen Lutheran HSC/IRBUnited States: Gundersen Lutheran Medical Research Dept.
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Complications and Failure
• Fistula

Intervention

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.

Locations

Country	Name	City	State
United States	Gundersen Lutheran Health System	La Crosse	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Gundersen Lutheran Medical Foundation	Gundersen Lutheran Health System

Country where clinical trial is conducted

United States, 

References & Publications (5)

Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. — View Citation

Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. — View Citation

Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. — View Citation

Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. — View Citation

Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost	Cost for the vascular clip device will be compared to cost of the handsewn technique.	1 year postoperative	No
Primary	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	No
Secondary	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	Yes