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Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

This study has been terminated.
(minimal accrual)
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation Identifier:
First received: August 16, 2012
Last updated: September 4, 2015
Last verified: September 2015
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 Intervention
Arteriovenous Fistula Complications and Failure Device: Clipped anastomosis Procedure: Handsewn anastomosis

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Kara Kallies, Gundersen Lutheran Medical Foundation:

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

Enrollment: 38
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: August 16, 2012
Last Updated: September 4, 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 processed this record on September 21, 2017