<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/NCT02239302</url>
  </required_header>
  <id_info>
    <org_study_id>13/LO/1665</org_study_id>
    <nct_id>NCT02239302</nct_id>
  </id_info>
  <brief_title>Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients</brief_title>
  <acronym>OPUS</acronym>
  <official_title>Obstructed Defaecation: Proctography Versus Ultrasound (TPUS and EVUS) in Symptomatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Croydon University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Croydon University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructed defaecation syndrome is a common problem in which patients experience difficulty&#xD;
      to evacuate stools and feel that the bowel is incompletely empty, which causes the need to&#xD;
      put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a&#xD;
      significant effect on social, physical, emotional and sexual wellbeing all of which have&#xD;
      impact on quality of life. These symptoms are caused by posterior compartment disorders such&#xD;
      as the last part of the large bowel bulging into the vagina (rectocele), the small bowel&#xD;
      pressing on the rectum (enterocele), a circumferential infolding of the rectal wall&#xD;
      (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate&#xD;
      (anismus).&#xD;
&#xD;
      Currently the evacuation proctogram is the gold standard for diagnosis of posterior&#xD;
      compartment disorders. This technique, however, exposes the patient to ionising radiation,&#xD;
      requires preparation of the small and large bowel with contrast and defaecation in a&#xD;
      non-private setting, which most women find embarrassing and unpleasant. Over the years,&#xD;
      research has focussed on identifying alternatives that are better tolerated to substitute&#xD;
      evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast&#xD;
      and a well-tolerated method for the dynamic and static imaging of the pelvic floor without&#xD;
      the use of ionising radiation. The level of agreement between transperineal ultrasound (TPUS)&#xD;
      and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to&#xD;
      proctography. The aim of this study is to assess the level of agreement between ultrasound&#xD;
      (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment&#xD;
      disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective is to assess the level of agreement between ultrasound (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment disorders</measure>
    <time_frame>up to 3 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">131</enrollment>
  <condition>Obstructed Defaecation Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients with symptomes of obstructed defaecation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients&#xD;
&#xD;
          -  Symptoms of obstructed defaecation&#xD;
&#xD;
          -  Planned for evacuation proctography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand English&#xD;
&#xD;
          -  Unwilling to consent for evacuation proctography&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Virgo intacta&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ranee Thakar, FRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Croydon University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Croydon University Hospital</name>
      <address>
        <city>Croydon</city>
        <state>Surrey</state>
        <zip>CR7 7YE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Croydon University Hospital</investigator_affiliation>
    <investigator_full_name>Ranee Thakar</investigator_full_name>
    <investigator_title>Consultant Urogynaecologist</investigator_title>
  </responsible_party>
  <keyword>Obstructed defaecation syndrome</keyword>
  <keyword>Transperineal Ultrasound</keyword>
  <keyword>Endovaginal Ultrasound</keyword>
  <keyword>Evacuation Proctography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT02239302
org study id: 13/LO/1665
nct id: NCT02239302
lead sponsor: 
has dmc: Yes
Obstructed defaecation syndrome is a common problem in which patients experience difficulty
      to evacuate stools and feel that the bowel is incompletely empty, which causes the need to
      put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a
      significant effect on social, physical, emotional and sexual wellbeing all of which have
      impact on quality of life. These symptoms are caused by posterior compartment disorders such
      as the last part of the large bowel bulging into the vagina (rectocele), the small bowel
      pressing on the rectum (enterocele), a circumferential infolding of the rectal wall
      (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate
      (anismus).

      Currently the evacuation proctogram is the gold standard for diagnosis of posterior
      compartment disorders. This technique, however, exposes the patient to ionising radiation,
      requires preparation of the small and large bowel with contrast and defaecation in a
      non-private setting, which most women find embarrassing and unpleasant. Over the years,
      research has focussed on identifying alternatives that are better tolerated to substitute
      evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast
      and a well-tolerated method for the dynamic and static imaging of the pelvic floor without
      the use of ionising radiation. The level of agreement between transperineal ultrasound (TPUS)
      and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to
      proctography. The aim of this study is to assess the level of agreement between ultrasound
      (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment
      disorders.
observational model: Cohort
time perspective: Prospective
measure: The primary objective is to assess the level of agreement between ultrasound (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment disorders
time frame: up to 3 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ranee Thakar, FRCOG
role: Principal Investigator
affiliation: Croydon University Hospital
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Croydon University Hospital
investigator full name: Ranee Thakar
investigator title: Consultant Urogynaecologist
mesh term: Syndrome