A Trial of Interrupted vs Continuous Suturing Techniques for Radiocephalic Fistulae

A Randonimised Trial Comparing Interrupted to Continuous Suturing Techniques in Radiocephalic Fistulae

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Failure
• Intervention / Treatment: Procedure: Interrupted; Procedure: Continuous

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G116NY
    • Recruiting
    • Department of Renal Surgery, Western Infirmary
    • Principal Investigator: David B Kingsmore, MBChB FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary patency	Defined as assited patency to permit the fistula to be used for dialysis	6 weeks, 1 year
Primary patency	Primary patency is defined as the unequivocal presence of thrill/ bruit and maturation of fistula so as to permit dialysis	1 year

Collaborators and Investigators

• Sponsor: Emma Aitken
• Investigators: Principal Investigator: David B Kingsmore, MBChB FRCS, NHS Greater Glasgow and Clyde

Publications and helpful links

General Publications

• Aitken E, McColl G, Kingsmore D. The Role of Qutenza(R) (Topical Capsaicin 8%) in Treating Neuropathic Pain from Critical Ischemia in Patients with End-Stage Renal Disease: An Observational Cohort Study. Pain Med. 2017 Feb 1;18(2):330-340. doi: 10.1093/pm/pnw139.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ANTICIPATED): August 1, 2013
• Study Completion (ANTICIPATED): May 1, 2014

Study Registration Dates

• First Submitted: October 8, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (ESTIMATE): October 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Vascular access; Haemodialysis; Suturing technique
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Fistula
• Other Study ID Numbers: 12/WS/0089