<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/NCT03784872</url>
  </required_header>
  <id_info>
    <org_study_id>46</org_study_id>
    <nct_id>NCT03784872</nct_id>
  </id_info>
  <brief_title>Laparoscopic Ventrosuspension for Women With Retroverted Uterus and Pelvic Pain Syndromes: A New Approach</brief_title>
  <official_title>Laparoscopic Ventrosuspension for Women With Retroverted Uterus and Pelvic Pain Syndromes: A New Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was&#xD;
      done. Under vision the skin overlying the attachment of the round ligament to the anterior&#xD;
      abdominal wall was incised followed by introduction of 30 curved needle attached to&#xD;
      absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under&#xD;
      laparoscopi vision. The needle was turned around the round ligament all through its length to&#xD;
      plicate it then the needle was pushed again beside its entry side to appear at the skin&#xD;
      incision. The same was repeated on the other side and both sutures were tied at the&#xD;
      subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of&#xD;
      the skin incision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was&#xD;
      done. Under vision the skin overlying the attachment of the round ligament to the anterior&#xD;
      abdominal wall was incised followed by introduction of 30 curved needle attached to&#xD;
      absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under&#xD;
      laparoscopi vision. The needle was turned around the round ligament all through its length to&#xD;
      plicate it then the needle was pushed again beside its entry side to appear at the skin&#xD;
      incision. The same was repeated on the other side and both sutures were tied at the&#xD;
      subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of&#xD;
      the skin incision using Vicryl 2/0 suture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain: VAS</measure>
    <time_frame>6 months after the operation</time_frame>
    <description>The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Chronic Pelvic Pain</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic guided Ventrosuspension</intervention_name>
    <description>Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with chronic pelvic pain for more than 6 months duration&#xD;
&#xD;
          -  women with retroverted retroflexed uterus&#xD;
&#xD;
          -  no response to analgesics&#xD;
&#xD;
          -  fit for laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with other causes of pelvic pain as ovarian cysts&#xD;
&#xD;
          -  women with neurological disorders&#xD;
&#xD;
          -  psychologically disturbed,&#xD;
&#xD;
          -  Women with systemic or pelvic infections,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>+201005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>fadel shaltout, MD</last_name>
    <phone>+201006023073</phone>
    <email>dr.shaltout@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Maged, MD</last_name>
      <phone>01005227404</phone>
      <email>prof.ahmedmaged@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Retroversion</mesh_term>
    <mesh_term>Pelvic Pain</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/NCT03784872
org study id: 46
nct id: NCT03784872
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was
      done. Under vision the skin overlying the attachment of the round ligament to the anterior
      abdominal wall was incised followed by introduction of 30 curved needle attached to
      absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under
      laparoscopi vision. The needle was turned around the round ligament all through its length to
      plicate it then the needle was pushed again beside its entry side to appear at the skin
      incision. The same was repeated on the other side and both sutures were tied at the
      subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of
      the skin incision.
In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was
      done. Under vision the skin overlying the attachment of the round ligament to the anterior
      abdominal wall was incised followed by introduction of 30 curved needle attached to
      absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under
      laparoscopi vision. The needle was turned around the round ligament all through its length to
      plicate it then the needle was pushed again beside its entry side to appear at the skin
      incision. The same was repeated on the other side and both sutures were tied at the
      subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of
      the skin incision using Vicryl 2/0 suture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative pain: VAS
time frame: 6 months after the operation
description: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints.
intervention type: Procedure
intervention name: Laparoscopic guided Ventrosuspension
description: Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.
criteria: 
gender: Female
gender based: Yes
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: Professor
last name: Ahmed Maged, MD
phone: +201005227404
email: prof.ahmedmaged@gmail.com
last name: fadel shaltout, MD
phone: +201006023073
email: dr.shaltout@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed M Maged, MD
investigator title: Principal investigator
mesh term: Uterine Retroversion
mesh term: Pelvic Pain
sharing ipd: Undecided