<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01704313</url>
  </required_header>
  <id_info>
    <org_study_id>12/WS/0089</org_study_id>
    <nct_id>NCT01704313</nct_id>
  </id_info>
  <brief_title>A Trial of Interrupted vs Continuous Suturing Techniques for Radiocephalic Fistulae</brief_title>
  <official_title>A Randonimised Trial Comparing Interrupted to Continuous Suturing Techniques in Radiocephalic Fistulae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emma Aitken</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with end-stage renal failure require dialysis to remove toxins from their blood.&#xD;
      Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an&#xD;
      AVF requires a short (~1hr) surgical procedure to join the artery and vein together.&#xD;
&#xD;
      There are limited potential sites for fistula creation. Generally it is preferrable to&#xD;
      utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude&#xD;
      subsequent use of the wrist should the initial fistula fail. The small diameter of artery and&#xD;
      vein at the wrist requires precise surgical technique.&#xD;
&#xD;
      There are two potential techniques in common use for creating the arterio-venous anastomosis&#xD;
      (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst&#xD;
      there are theoretical advantages to the interrupted technique, it is uncertain if these&#xD;
      translate clinically into better success of creating the fistula. The aim of this study is&#xD;
      therefore to compare the clinical success of the two techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The micro-vascular anastamosis required for creation of a radio-cephalic arteriovenous&#xD;
      fistula, is technically challenging surgery. Primary patency rates for radiocephalic fistula&#xD;
      varying between 50-75% in the literature and 60-95% within over own department. It is&#xD;
      important to optimise primary patency rates as initial failure subjects the patient to risks&#xD;
      of further surgery and often necessiates them commencing dialysis via a tunnelled line (which&#xD;
      is less effective and associated with increased risks of infection) whilst a second attempt&#xD;
      at creating a fistula is undertaken.&#xD;
&#xD;
      Multiple variations of both continuous and interrupted suture technique are described in the&#xD;
      vascular literature, both in animal models of arterio-venous fistulae and in clinical studies&#xD;
      in other specialities. However no study has compared the two techniques within clinical&#xD;
      practice.&#xD;
&#xD;
      Evidence from in vivo animal studies is variable. Several authors have shown no difference in&#xD;
      primary patency rates achieved with continuous suture versus interrupted suture technique&#xD;
      used for anastomosis(Chen &amp; Chen, 2001; Wilasrusmee et al 2007). Others have suggested that&#xD;
      using a continuous suture causes a reduced cross-sectional area of the anastomosis compared&#xD;
      to an interrupted technique (Tozzi &amp; Hayoz, 2001). Similarly an interrupted suture technique&#xD;
      permits expansion of the vessel at physiological pressures where as continuous technique does&#xD;
      not (Norbert &amp; Philip, 1996; Gerdisch &amp; Hinkamp, 2003). This loss of compliance at the&#xD;
      anastomosis can in turn lead to intimal hyperplasia, causing poor blood flow and failure of&#xD;
      the anastamosis (Dorbin, 1994), indicating potential theoretical benefits of interrupted&#xD;
      suturing.&#xD;
&#xD;
      There are no clinical studies comparing the two techniques and variation in practice varies&#xD;
      considerably. The aim of this study therefore is the compare patency rates in radiocephalic&#xD;
      fistulae by randomising to one or other anastomotic technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency</measure>
    <time_frame>6 weeks</time_frame>
    <description>Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary patency</measure>
    <time_frame>6 weeks, 1 year</time_frame>
    <description>Defined as assited patency to permit the fistula to be used for dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary patency</measure>
    <time_frame>1 year</time_frame>
    <description>Primary patency is defined as the unequivocal presence of thrill/ bruit and maturation of fistula so as to permit dialysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>End Stage Renal Failure</condition>
  <arm_group>
    <arm_group_label>Interrupted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interrupted suturing technique used around heel of anastomosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous suturing technique used for the anastomosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Interrupted</intervention_name>
    <description>Interrupted suturing technique used aroudn the heel of the vascular anastomosis</description>
    <arm_group_label>Interrupted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous</intervention_name>
    <description>Continuous suturing technique used for the anastomosis</description>
    <arm_group_label>Continuous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  End stage renal failure&#xD;
&#xD;
          -  Undergoing surgery for creation of a radiocephalic fistula&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Declines participation&#xD;
&#xD;
          -  Unable to speak English or provide informed consent&#xD;
&#xD;
          -  Radial artery diameter &lt;1.8mm&#xD;
&#xD;
          -  Cephalic wrist diameter at wrist &lt;2mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David B Kingsmore, MBChB FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Greater Glasgow and Clyde</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emma L Aitken, MBChB</last_name>
    <phone>01412111750</phone>
    <email>EmmaAitken@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David B Kingsmore, MBChB FRCS</last_name>
    <phone>01412111750</phone>
    <email>david.kingsmore@ggc.scot.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Renal Surgery, Western Infirmary</name>
      <address>
        <city>Glasgow</city>
        <zip>G116NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David B Kingsmore, MBChB frcs</last_name>
      <phone>01412111750</phone>
      <email>david.kingsmore@ggc.scot.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Emma L Aitken, MBChB</last_name>
      <phone>01412111750</phone>
      <email>EmmaAitken@nhs.net</email>
    </contact_backup>
    <investigator>
      <last_name>Emma L Aitken, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David B Kingsmore, MBChB FRCS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>NHS Greater Glasgow and Clyde</investigator_affiliation>
    <investigator_full_name>Emma Aitken</investigator_full_name>
    <investigator_title>Clinical Research Fellow, Renal Surgery</investigator_title>
  </responsible_party>
  <keyword>Vascular access</keyword>
  <keyword>Haemodialysis</keyword>
  <keyword>Suturing technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704313
org study id: 12/WS/0089
nct id: NCT01704313
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Primary patency
time frame: 6 weeks
description: Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis
measure: Secondary patency
time frame: 6 weeks, 1 year
description: Defined as assited patency to permit the fistula to be used for dialysis
measure: Primary patency
time frame: 1 year
description: Primary patency is defined as the unequivocal presence of thrill/ bruit and maturation of fistula so as to permit dialysis
arm group label: Interrupted
arm group type: Experimental
description: Interrupted suturing technique used around heel of anastomosis
arm group label: Continuous
arm group type: Active Comparator
description: Continuous suturing technique used for the anastomosis
intervention type: Procedure
intervention name: Interrupted
description: Interrupted suturing technique used aroudn the heel of the vascular anastomosis
arm group label: Interrupted
intervention type: Procedure
intervention name: Continuous
description: Continuous suturing technique used for the anastomosis
arm group label: Continuous
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David B Kingsmore, MBChB FRCS
role: Principal Investigator
affiliation: NHS Greater Glasgow and Clyde
last name: Emma L Aitken, MBChB
phone: 01412111750
email: EmmaAitken@nhs.net
last name: David B Kingsmore, MBChB FRCS
phone: 01412111750
email: david.kingsmore@ggc.scot.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: NHS Greater Glasgow and Clyde
investigator full name: Emma Aitken
investigator title: Clinical Research Fellow, Renal Surgery
mesh term: Kidney Failure, Chronic
mesh term: Fistula