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A Trial of Interrupted vs Continuous Suturing Techniques for Radiocephalic Fistulae

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ClinicalTrials.gov Identifier: NCT01704313
Recruitment Status : Unknown
Verified October 2012 by Emma Aitken, NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde

Brief Summary:

Patients with end-stage renal failure require dialysis to remove toxins from their blood. Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an AVF requires a short (~1hr) surgical procedure to join the artery and vein together.

There are limited potential sites for fistula creation. Generally it is preferrable to utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude subsequent use of the wrist should the initial fistula fail. The small diameter of artery and vein at the wrist requires precise surgical technique.

There are two potential techniques in common use for creating the arterio-venous anastomosis (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst there are theoretical advantages to the interrupted technique, it is uncertain if these translate clinically into better success of creating the fistula. The aim of this study is therefore to compare the clinical success of the two techniques.


Condition or disease Intervention/treatment Phase
End Stage Renal Failure Procedure: Interrupted Procedure: Continuous Not Applicable

Detailed Description:

The micro-vascular anastamosis required for creation of a radio-cephalic arteriovenous fistula, is technically challenging surgery. Primary patency rates for radiocephalic fistula varying between 50-75% in the literature and 60-95% within over own department. It is important to optimise primary patency rates as initial failure subjects the patient to risks of further surgery and often necessiates them commencing dialysis via a tunnelled line (which is less effective and associated with increased risks of infection) whilst a second attempt at creating a fistula is undertaken.

Multiple variations of both continuous and interrupted suture technique are described in the vascular literature, both in animal models of arterio-venous fistulae and in clinical studies in other specialities. However no study has compared the two techniques within clinical practice.

Evidence from in vivo animal studies is variable. Several authors have shown no difference in primary patency rates achieved with continuous suture versus interrupted suture technique used for anastomosis(Chen & Chen, 2001; Wilasrusmee et al 2007). Others have suggested that using a continuous suture causes a reduced cross-sectional area of the anastomosis compared to an interrupted technique (Tozzi & Hayoz, 2001). Similarly an interrupted suture technique permits expansion of the vessel at physiological pressures where as continuous technique does not (Norbert & Philip, 1996; Gerdisch & Hinkamp, 2003). This loss of compliance at the anastomosis can in turn lead to intimal hyperplasia, causing poor blood flow and failure of the anastamosis (Dorbin, 1994), indicating potential theoretical benefits of interrupted suturing.

There are no clinical studies comparing the two techniques and variation in practice varies considerably. The aim of this study therefore is the compare patency rates in radiocephalic fistulae by randomising to one or other anastomotic technique.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randonimised Trial Comparing Interrupted to Continuous Suturing Techniques in Radiocephalic Fistulae
Study Start Date : May 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Interrupted
Interrupted suturing technique used around heel of anastomosis
Procedure: Interrupted
Interrupted suturing technique used aroudn the heel of the vascular anastomosis

Active Comparator: Continuous
Continuous suturing technique used for the anastomosis
Procedure: Continuous
Continuous suturing technique used for the anastomosis




Primary Outcome Measures :
  1. Primary patency [ Time Frame: 6 weeks ]
    Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis


Secondary Outcome Measures :
  1. Secondary patency [ Time Frame: 6 weeks, 1 year ]
    Defined as assited patency to permit the fistula to be used for dialysis

  2. Primary patency [ Time Frame: 1 year ]
    Primary patency is defined as the unequivocal presence of thrill/ bruit and maturation of fistula so as to permit dialysis



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

Inclusion Criteria:

  • End stage renal failure
  • Undergoing surgery for creation of a radiocephalic fistula

Exclusion Criteria:

  • Declines participation
  • Unable to speak English or provide informed consent
  • Radial artery diameter <1.8mm
  • Cephalic wrist diameter at wrist <2mm

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 ClinicalTrials.gov identifier (NCT number): NCT01704313


Contacts
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Contact: Emma L Aitken, MBChB 01412111750 EmmaAitken@nhs.net
Contact: David B Kingsmore, MBChB FRCS 01412111750 david.kingsmore@ggc.scot.nhs.uk

Locations
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United Kingdom
Department of Renal Surgery, Western Infirmary Recruiting
Glasgow, United Kingdom, G116NY
Contact: David B Kingsmore, MBChB frcs    01412111750    david.kingsmore@ggc.scot.nhs.uk   
Contact: Emma L Aitken, MBChB    01412111750    EmmaAitken@nhs.net   
Sub-Investigator: Emma L Aitken, MBChB         
Principal Investigator: David B Kingsmore, MBChB FRCS         
Sponsors and Collaborators
Emma Aitken
Investigators
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Principal Investigator: David B Kingsmore, MBChB FRCS NHS Greater Glasgow and Clyde

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emma Aitken, Clinical Research Fellow, Renal Surgery, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01704313     History of Changes
Other Study ID Numbers: 12/WS/0089
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Emma Aitken, NHS Greater Glasgow and Clyde:
Vascular access
Haemodialysis
Suturing technique
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Fistula
Pathological Conditions, Anatomical
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic