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A Trial of Interrupted vs Continuous Suturing Techniques for Radiocephalic Fistulae

Primary Purpose

End Stage Renal Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Interrupted
Continuous
Sponsored by
Emma Aitken
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure focused on measuring Vascular access, Haemodialysis, Suturing technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Renal Surgery, Western InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interrupted

Continuous

Arm Description

Interrupted suturing technique used around heel of anastomosis

Continuous suturing technique used for the anastomosis

Outcomes

Primary Outcome Measures

Primary patency
Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis

Secondary Outcome Measures

Secondary patency
Defined as assited patency to permit the fistula to be used for dialysis
Primary patency
Primary patency is defined as the unequivocal presence of thrill/ bruit and maturation of fistula so as to permit dialysis

Full Information

First Posted
October 8, 2012
Last Updated
October 10, 2012
Sponsor
Emma Aitken
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1. Study Identification

Unique Protocol Identification Number
NCT01704313
Brief Title
A Trial of Interrupted vs Continuous Suturing Techniques for Radiocephalic Fistulae
Official Title
A Randonimised Trial Comparing Interrupted to Continuous Suturing Techniques in Radiocephalic Fistulae
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emma Aitken

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure
Keywords
Vascular access, Haemodialysis, Suturing technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interrupted
Arm Type
Experimental
Arm Description
Interrupted suturing technique used around heel of anastomosis
Arm Title
Continuous
Arm Type
Active Comparator
Arm Description
Continuous suturing technique used for the anastomosis
Intervention Type
Procedure
Intervention Name(s)
Interrupted
Intervention Description
Interrupted suturing technique used aroudn the heel of the vascular anastomosis
Intervention Type
Procedure
Intervention Name(s)
Continuous
Intervention Description
Continuous suturing technique used for the anastomosis
Primary Outcome Measure Information:
Title
Primary patency
Description
Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Secondary patency
Description
Defined as assited patency to permit the fistula to be used for dialysis
Time Frame
6 weeks, 1 year
Title
Primary patency
Description
Primary patency is defined as the unequivocal presence of thrill/ bruit and maturation of fistula so as to permit dialysis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma L Aitken, MBChB
Phone
01412111750
Email
EmmaAitken@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
David B Kingsmore, MBChB FRCS
Phone
01412111750
Email
david.kingsmore@ggc.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Kingsmore, MBChB FRCS
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Renal Surgery, Western Infirmary
City
Glasgow
ZIP/Postal Code
G116NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David B Kingsmore, MBChB frcs
Phone
01412111750
Email
david.kingsmore@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Emma L Aitken, MBChB
Phone
01412111750
Email
EmmaAitken@nhs.net
First Name & Middle Initial & Last Name & Degree
Emma L Aitken, MBChB
First Name & Middle Initial & Last Name & Degree
David B Kingsmore, MBChB FRCS

12. IPD Sharing Statement

Citations:
PubMed Identifier
28204726
Citation
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.
Results Reference
derived

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A Trial of Interrupted vs Continuous Suturing Techniques for Radiocephalic Fistulae

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