<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/NCT03012464</url>
  </required_header>
  <id_info>
    <org_study_id>mansourau2017</org_study_id>
    <nct_id>NCT03012464</nct_id>
  </id_info>
  <brief_title>Pathologic Assessment of Rectal Prolapse in the Young</brief_title>
  <official_title>Pathologic and Functional Assessment of Rectal Prolapse in Young Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients aging less than 45 years with rectal prolapse will undergo full pathologic and&#xD;
      functional assessment to determine the underlying etiology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Full clinical assessment of the patients will be conducted by history taking querying the&#xD;
      type and duration of symptoms, associated medical conditions, history of previous surgery for&#xD;
      rectal prolapse, and presence of fecal incontinence which will be graded by Wexner continence&#xD;
      score. In addition, patients will undergo thorough general and local examination to determine&#xD;
      the type of rectal prolapse (internal or external) and the condition of the anal sphincters&#xD;
      and pelvic floor muscles.&#xD;
&#xD;
      Functional assessment of the anorectal region will be done by anal manometry to measure the&#xD;
      resting and squeeze anal pressures, rectal sensation and compliance; endorectal&#xD;
      ultrasonography to assess the integrity of the anal sphincters; and pudendal nerve terminal&#xD;
      motor latency (PNTML) to exclude pudendal neuropathy.&#xD;
&#xD;
      Random biopsies (2-4 in number) will be taken from the pelvic floor muscles, external anal&#xD;
      sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of&#xD;
      rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be&#xD;
      preserved in formalin solution and will be sent for histopathological examination. Tissue&#xD;
      samples will be subjected to immunohistochemistry to calculate the ratio between collagen&#xD;
      type I and type III, and to reveal any myopathic or degenerative changes. Additionally,&#xD;
      schistosomal affection of the pelvic floor muscles will be detected by immunohistochemistry&#xD;
      examination for the ova of schistosomal mansoni.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Collagen I:III ratio</measure>
    <time_frame>immediate after surgery</time_frame>
    <description>Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Rectal Prolapse</condition>
  <arm_group>
    <arm_group_label>Pathologic and functional assessment</arm_group_label>
    <description>Patients of both genders, aging below 45 years with internal or external rectal prolapse</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pathologic and functional assessment</intervention_name>
    <description>Random biopsies will be taken from the pelvic floor muscles, external anal sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be subjected to immunohistochemistry to calculate the ratio between collagen type I and type III, and to reveal any myopathic or degenerative changes</description>
    <arm_group_label>Pathologic and functional assessment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of both genders aging below 45 years with primary or recurrent rectal prolapse,&#xD;
        whether internal or external prolapse, will be included. Patients above 45 years, patients&#xD;
        with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients&#xD;
        with documented psychiatric or mental disorders will be excluded&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders aging below 45 years with primary or recurrent rectal&#xD;
             prolapse, whether internal or external prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients above 45 years, patients with associated anorectal pathology as anal fissure,&#xD;
             hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh H Emile, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sameh H Emile, M.D</last_name>
    <phone>1006267150</phone>
    <email>sameh200@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura University hospitals</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sameh H Emile, M.D.</last_name>
      <phone>+201006267150</phone>
      <email>sameh200@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mansoura university hospital</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sameh Emile, M.D</last_name>
      <email>sameh200@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Sameh Emile</investigator_full_name>
    <investigator_title>Lecturer of general surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Prolapse</mesh_term>
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </patient_data>
  <!-- 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/NCT03012464
org study id: mansourau2017
nct id: NCT03012464
lead sponsor: 
has dmc: Yes
Patients aging less than 45 years with rectal prolapse will undergo full pathologic and
      functional assessment to determine the underlying etiology.
Full clinical assessment of the patients will be conducted by history taking querying the
      type and duration of symptoms, associated medical conditions, history of previous surgery for
      rectal prolapse, and presence of fecal incontinence which will be graded by Wexner continence
      score. In addition, patients will undergo thorough general and local examination to determine
      the type of rectal prolapse (internal or external) and the condition of the anal sphincters
      and pelvic floor muscles.

      Functional assessment of the anorectal region will be done by anal manometry to measure the
      resting and squeeze anal pressures, rectal sensation and compliance; endorectal
      ultrasonography to assess the integrity of the anal sphincters; and pudendal nerve terminal
      motor latency (PNTML) to exclude pudendal neuropathy.

      Random biopsies (2-4 in number) will be taken from the pelvic floor muscles, external anal
      sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of
      rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be
      preserved in formalin solution and will be sent for histopathological examination. Tissue
      samples will be subjected to immunohistochemistry to calculate the ratio between collagen
      type I and type III, and to reveal any myopathic or degenerative changes. Additionally,
      schistosomal affection of the pelvic floor muscles will be detected by immunohistochemistry
      examination for the ova of schistosomal mansoni.
observational model: Cohort
time perspective: Prospective
measure: Collagen I:III ratio
time frame: immediate after surgery
description: Pathologic assessment of the taken biopsies to examine the ratio between collagen type I and type III
arm group label: Pathologic and functional assessment
description: Patients of both genders, aging below 45 years with internal or external rectal prolapse
intervention type: Other
intervention name: Pathologic and functional assessment
description: Random biopsies will be taken from the pelvic floor muscles, external anal sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be subjected to immunohistochemistry to calculate the ratio between collagen type I and type III, and to reveal any myopathic or degenerative changes
arm group label: Pathologic and functional assessment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 45 Years
healthy volunteers: No
last name: Sameh H Emile, M.D.
role: Principal Investigator
affiliation: Mansoura University
last name: Sameh H Emile, M.D
phone: 1006267150
email: sameh200@hotmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Emile
investigator title: Lecturer of general surgery
mesh term: Rectal Prolapse
mesh term: Prolapse
sharing ipd: No
ipd description: No plan to share IPD