Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

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

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.

Study Overview

• Status: Terminated
• Conditions: Arteriovenous Fistula Complications and Failure
• Intervention / Treatment: Device: Clipped anastomosis; Procedure: Handsewn anastomosis

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clipped anastomosis; A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.	Device: Clipped anastomosis; The vascular clip devise will be used to complete the anastomosis during fistula creation.; Other Names: Anastoclip (Le Maitre)
Active Comparator: Handsewn anastomosis; A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.	Procedure: Handsewn anastomosis; a handsewn anastomosis technique will be used during fistula creation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost	Cost for the vascular clip device will be compared to cost of the handsewn technique.	1 year postoperative

Collaborators and Investigators

• Sponsor: Gundersen Lutheran Medical Foundation
• Collaborators: Gundersen Lutheran Health System
• Investigators: Principal Investigator: Clark A Davis, MD, Gundersen Lutheran Health System

Publications and helpful links

General Publications

• 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. doi: 10.1067/mva.2001.112806.
• 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. doi: 10.1016/j.amjsurg.2003.08.007.
• 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.
• 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. doi: 10.1016/s0741-5214(03)00412-9.
• 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. doi: 10.1177/153857440503900509.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Complications; Arteriovenous fistula; Patency; Surgical anastomosis; Dialysis access
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2-12-07-002