<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/NCT02976870</url>
  </required_header>
  <id_info>
    <org_study_id>12SP006</org_study_id>
    <nct_id>NCT02976870</nct_id>
  </id_info>
  <brief_title>Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)</brief_title>
  <acronym>HAALIF</acronym>
  <official_title>Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient&#xD;
      in order to access the spine. During this process, several internal structures are pushed&#xD;
      aside in order to gain access. One of these structures is the ureter, whose function is to&#xD;
      drain urine from the kidney to the bladder. One potential complication that can arise from&#xD;
      this is dilation of the kidney - known as hydronephrosis. The aim of this study is to&#xD;
      identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is&#xD;
      complication, in order to bring this to the attention of health care professionals when&#xD;
      considering this kind of surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 40 patients who have had ALIF surgery will be invited to have an ultrasound scan&#xD;
      of their kidney on the side where the operation was performed (where the scar is). Should&#xD;
      hydronephrosis of this kidney be detected, the investigators will go on to scan the second&#xD;
      kidney. Should hydronephrosis be detected the patient will be given a letter to take to their&#xD;
      General Practitioner (GP) advising them to be referred to a Urologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of hydronephrosis on ultrasound scan</measure>
    <time_frame>12 month</time_frame>
    <description>Each participant will have an ultrasound scan of their kidney. After this ultrasound scan participant will have no further involvement in the study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Hydronephrosis</condition>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned.</description>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Has the mental capacity to provide informed consent for participation within the study&#xD;
&#xD;
          -  Patients who have had anterior lumbar spinal surgery at least 12 months ago and no&#xD;
             longer than 5 years ago&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand written or verbal information regarding the study&#xD;
&#xD;
          -  Multiple abdominal surgeries prior to spinal surgery&#xD;
&#xD;
          -  Previous renal complication such as renal strictures or hydronephrosis/use of stents&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Structural anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bronek Boszczyk, PD. Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Centre for Spinal Studies and Surgery, Queen's Medical Centre, Nottingham, NG7 2UH.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hydronephrosis</keyword>
  <keyword>Anterior Lumbar Interbody Fusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydronephrosis</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/NCT02976870
org study id: 12SP006
nct id: NCT02976870
lead sponsor: 
has dmc: No
Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient
      in order to access the spine. During this process, several internal structures are pushed
      aside in order to gain access. One of these structures is the ureter, whose function is to
      drain urine from the kidney to the bladder. One potential complication that can arise from
      this is dilation of the kidney - known as hydronephrosis. The aim of this study is to
      identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is
      complication, in order to bring this to the attention of health care professionals when
      considering this kind of surgery.
A total of 40 patients who have had ALIF surgery will be invited to have an ultrasound scan
      of their kidney on the side where the operation was performed (where the scar is). Should
      hydronephrosis of this kidney be detected, the investigators will go on to scan the second
      kidney. Should hydronephrosis be detected the patient will be given a letter to take to their
      General Practitioner (GP) advising them to be referred to a Urologist.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Identification of hydronephrosis on ultrasound scan
time frame: 12 month
description: Each participant will have an ultrasound scan of their kidney. After this ultrasound scan participant will have no further involvement in the study.
arm group label: Ultrasound
arm group type: Experimental
description: Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned.
intervention type: Radiation
intervention name: Ultrasound
description: Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned.
arm group label: Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bronek Boszczyk, PD. Dr.med.
role: Principal Investigator
affiliation: The Centre for Spinal Studies and Surgery, Queen's Medical Centre, Nottingham, NG7 2UH.
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hydronephrosis