<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/NCT03801291</url>
  </required_header>
  <id_info>
    <org_study_id>masnoura99</org_study_id>
    <nct_id>NCT03801291</nct_id>
  </id_info>
  <brief_title>Transvaginal Versus Transperineal Repair of Rectocele</brief_title>
  <official_title>Transvaginal Versus Transperineal Repair of Anterior 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>
      Patients with anterior rectocele were randomized to undergo either transvaginal or&#xD;
      transperineal repair. The primary outcome of the study was improvement in constipation at 6&#xD;
      and 12 months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">January 7, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Improvement in constipation</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
    <description>decrease in Wexner constipation score by 25%</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Rectocele</condition>
  <arm_group>
    <arm_group_label>Transvaginal repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Repair of anterior rectocele via the vagina</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transperineal repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Repair of anterior rectocele via the perineum</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvaginal repair</intervention_name>
    <description>Vaginal incision through which plication of the rectovaginal septum is done</description>
    <arm_group_label>Transvaginal repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transperineal repair</intervention_name>
    <description>Perineal incision through which plication of the rectovaginal septum is done</description>
    <arm_group_label>Transperineal repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult female patients with anterior rectocele&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male patients.&#xD;
&#xD;
          -  Combined rectocele with internal rectal prolapse.&#xD;
&#xD;
          -  Anismus.&#xD;
&#xD;
          -  Associated anorectal condition such as hemorrhoids and anal fissure.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Unwilling to participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh H Emile</last_name>
    <role>Principal Investigator</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>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</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>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/NCT03801291
org study id: masnoura99
nct id: NCT03801291
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with anterior rectocele were randomized to undergo either transvaginal or
      transperineal repair. The primary outcome of the study was improvement in constipation at 6
      and 12 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Improvement in constipation
time frame: 6 and 12 months after surgery
description: decrease in Wexner constipation score by 25%
arm group label: Transvaginal repair
arm group type: Active Comparator
description: Repair of anterior rectocele via the vagina
arm group label: Transperineal repair
arm group type: Active Comparator
description: Repair of anterior rectocele via the perineum
intervention type: Procedure
intervention name: Transvaginal repair
description: Vaginal incision through which plication of the rectovaginal septum is done
arm group label: Transvaginal repair
intervention type: Procedure
intervention name: Transperineal repair
description: Perineal incision through which plication of the rectovaginal septum is done
arm group label: Transperineal repair
criteria: 
gender: Female
gender based: Yes
gender description: Female only
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sameh H Emile
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Emile
investigator title: Lecturer of general surgery
mesh term: Rectocele
sharing ipd: Undecided