Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arteriovenous Fistula Complications and Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Clipped anastomosis

A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.

Group Type EXPERIMENTAL

Clipped anastomosis

Intervention Type DEVICE

The vascular clip devise will be used to complete the anastomosis during fistula creation.

Handsewn anastomosis

A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.

Group Type ACTIVE_COMPARATOR

Handsewn anastomosis

Intervention Type PROCEDURE

a handsewn anastomosis technique will be used during fistula creation.

Interventions

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Clipped anastomosis

The vascular clip devise will be used to complete the anastomosis during fistula creation.

Intervention Type DEVICE

Handsewn anastomosis

a handsewn anastomosis technique will be used during fistula creation.

Intervention Type PROCEDURE

Other Intervention Names

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Anastoclip (Le Maitre)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No