<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/NCT04502953</url>
  </required_header>
  <id_info>
    <org_study_id>Mansoura20201</org_study_id>
    <nct_id>NCT04502953</nct_id>
  </id_info>
  <brief_title>Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele</brief_title>
  <official_title>Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We assumed that the technique of plication of the rectovaginal septum and rectal wall may&#xD;
      factor in providing better and more sustained repair that confers more satisfactory&#xD;
      improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR&#xD;
      with vertical plication of the rectovaginal septum as compared to the horizontal plication&#xD;
      with regards to improvement in ODS, recurrence of rectocele, postoperative complications and&#xD;
      dyspareunia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete cure of symptoms</measure>
    <time_frame>12 months after repair</time_frame>
    <description>Absence of symptoms of constipation with Wexner score &lt;2</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Rectocele</condition>
  <arm_group>
    <arm_group_label>Vertical plication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vertical plication of the rectovaginal septum was done</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Horizontal plication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Horizontal plication of the rectovaginal septum was done</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vertical plication</intervention_name>
    <description>Vertical plication of the rectovaginal septum was done</description>
    <arm_group_label>Vertical plication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Horizontal plication</intervention_name>
    <description>Horizontal plication of the rectovaginal septum was done</description>
    <arm_group_label>Horizontal plication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Vertical plication of the rectovaginal septum was done&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with ODS caused by conditions other than rectocele such as anismus and&#xD;
             internal rectal prolapse&#xD;
&#xD;
          -  patients with slow transit constipation.&#xD;
&#xD;
          -  patients with recurrent rectocele after previous surgery.&#xD;
&#xD;
          -  patients with pre-existing FI&#xD;
&#xD;
          -  patients with associated anorectal pathology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh H Emile</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university hospital</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectocele</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04502953
org study id: Mansoura20201
nct id: NCT04502953
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We assumed that the technique of plication of the rectovaginal septum and rectal wall may
      factor in providing better and more sustained repair that confers more satisfactory
      improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR
      with vertical plication of the rectovaginal septum as compared to the horizontal plication
      with regards to improvement in ODS, recurrence of rectocele, postoperative complications and
      dyspareunia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Complete cure of symptoms
time frame: 12 months after repair
description: Absence of symptoms of constipation with Wexner score <2
arm group label: Vertical plication
arm group type: Active Comparator
description: Vertical plication of the rectovaginal septum was done
arm group label: Horizontal plication
arm group type: Active Comparator
description: Horizontal plication of the rectovaginal septum was done
intervention type: Procedure
intervention name: Vertical plication
description: Vertical plication of the rectovaginal septum was done
arm group label: Vertical plication
intervention type: Procedure
intervention name: Horizontal plication
description: Horizontal plication of the rectovaginal septum was done
arm group label: Horizontal plication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sameh H Emile
role: Study Chair
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Rectocele
sharing ipd: Undecided