Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01669850
Recruitment Status : Terminated (minimal accrual)
First Posted : August 21, 2012
Last Update Posted : September 7, 2015
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, 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.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Complications and Failure Device: Clipped anastomosis Procedure: Handsewn anastomosis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
Study Start Date : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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 Name: 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. Cost [ Time Frame: 1 year postoperative ]
    Cost for the vascular clip device will be compared to cost of the handsewn technique.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01669850

United States, Wisconsin
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Gundersen Lutheran Health System
Principal Investigator: Clark A Davis, MD Gundersen Lutheran Health System

Responsible Party: Kara Kallies, Advanced Research Associate, on behalf of Clark Davis, MD (PI), Gundersen Lutheran Medical Foundation Identifier: NCT01669850     History of Changes
Other Study ID Numbers: 2-12-07-002
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015

Keywords provided by Kara Kallies, Gundersen Lutheran Medical Foundation:
Chronic kidney disease
Arteriovenous fistula
Surgical anastomosis
Dialysis access

Additional relevant MeSH terms:
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities