Trial record 4 of 75 for:    "Arteriovenous Fistula"

Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT01669850
First received: August 16, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Gundersen Lutheran Medical Foundation:

Primary Outcome Measures:
  • Patency rates [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Cost for the vascular clip device will be compared to cost of the handsewn technique.


Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Primary Completion Date: August 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01669850

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

Publications:
Responsible Party: Kara Kallies, Advanced Research Associate, on behalf of Clark Davis, MD (PI), Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT01669850     History of Changes
Other Study ID Numbers: 2-12-07-002
Study First Received: August 16, 2012
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Gundersen Lutheran HSC/IRB
United States: Gundersen Lutheran Medical Research Dept.

Keywords provided by Gundersen Lutheran Medical Foundation:
Chronic kidney disease
Arteriovenous fistula
Surgical anastomosis
Complications
Patency
Dialysis access

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

ClinicalTrials.gov processed this record on October 21, 2014