<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/NCT04410393</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK- 2020/06</org_study_id>
    <nct_id>NCT04410393</nct_id>
  </id_info>
  <brief_title>Sacrocolpopexy and Lateral Suspension Operations</brief_title>
  <official_title>Comparison of the Sacrocolpopexy Operation and Lateral Suspension Operations Performed in the Treatment of Vaginal Cuff Prolapse in Patients With Hysterectomized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients&#xD;
      who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy&#xD;
      and the other is lateral suspension. the investigators want to compare the results of&#xD;
      patients undergoing these two operations. Thus, the difference between surgical methods will&#xD;
      be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of&#xD;
      operation. After the operations, the patients will be followed up, a questionnaire will be&#xD;
      applied to the postoperative patients and some questions will be asked. Pelvic examinations&#xD;
      will also be performed and they will be evaluated for recurrence and complication. At the end&#xD;
      of the study, the data of both groups will be compared and their superiority to each other&#xD;
      will be shown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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>recurrence</measure>
    <time_frame>1 years</time_frame>
    <description>Patients will be followed up for 1 year after surgery and will be evaluated for recurrence at 1, 6 and 12 months.&#xD;
degree of uterine desensus cystocele and rectocele degree to be examined Recurrence rate will be defined by pelvic examination according to POP-Q scoring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>1 years</time_frame>
    <description>Patients will be followed up for 1 year after the operation and will be evaluated for complications at 1, 6 and 12 months.&#xD;
bleeding ( bleeding rate will be specified in milliliters ) the risk of infection (According to the findings, there is an infection with / without infection.)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Prolapse</condition>
  <condition>Cuff</condition>
  <arm_group>
    <arm_group_label>sacrocolpopexy patients</arm_group_label>
    <description>Patients who underwent sacrocolpopexy for the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lateral suspension surgery patients</arm_group_label>
    <description>Patients who underwent lateral suspension surgery for vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vaginal cuff prolapse surgery</intervention_name>
    <description>Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes</description>
    <arm_group_label>lateral suspension surgery patients</arm_group_label>
    <arm_group_label>sacrocolpopexy patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Different surgical methods can be used in the treatment of vaginal cuff prolapse in&#xD;
        patients who had previously undergone hysterectomy for benign reasons. One of these is&#xD;
        sacrocolpopexy and the other is lateral suspension. The investigators will form study&#xD;
        groups of patients who underwent these two operations.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had previously undergone hysterectomy for benign causes&#xD;
&#xD;
          -  Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up&#xD;
&#xD;
          -  And for this, patients scheduled for operation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic diseases or medications that interfere with the operation&#xD;
&#xD;
          -  Patients with oncology operated for malignant cause&#xD;
&#xD;
          -  Non-localized patients with vaginal cuff prolapse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kanuni Sultan Süleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>33404</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pınar Kadirogulları</investigator_full_name>
    <investigator_title>Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sacrocolpopexy</keyword>
  <keyword>Lateral Suspension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</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/NCT04410393
org study id: ATADEK- 2020/06
nct id: NCT04410393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients
      who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy
      and the other is lateral suspension. the investigators want to compare the results of
      patients undergoing these two operations. Thus, the difference between surgical methods will
      be investigated.
Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of
      operation. After the operations, the patients will be followed up, a questionnaire will be
      applied to the postoperative patients and some questions will be asked. Pelvic examinations
      will also be performed and they will be evaluated for recurrence and complication. At the end
      of the study, the data of both groups will be compared and their superiority to each other
      will be shown.
observational model: Cohort
time perspective: Prospective
measure: recurrence
time frame: 1 years
description: Patients will be followed up for 1 year after surgery and will be evaluated for recurrence at 1, 6 and 12 months.
degree of uterine desensus cystocele and rectocele degree to be examined Recurrence rate will be defined by pelvic examination according to POP-Q scoring.
measure: complications
time frame: 1 years
description: Patients will be followed up for 1 year after the operation and will be evaluated for complications at 1, 6 and 12 months.
bleeding ( bleeding rate will be specified in milliliters ) the risk of infection (According to the findings, there is an infection with / without infection.)
arm group label: sacrocolpopexy patients
description: Patients who underwent sacrocolpopexy for the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes
arm group label: lateral suspension surgery patients
description: Patients who underwent lateral suspension surgery for vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes
intervention type: Procedure
intervention name: vaginal cuff prolapse surgery
description: Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes
arm group label: lateral suspension surgery patients
arm group label: sacrocolpopexy patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Kadirogulları
investigator title: Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator
mesh term: Prolapse