xml: <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/NCT06004089</url>
    </required_header>
    <id_info>
      <org_study_id>2022/514/222/30</org_study_id>
      <nct_id>NCT06004089</nct_id>
    </id_info>
    <brief_title>Vaginal Transluminal Endoscopic Sacrocolpopexy</brief_title>
    <official_title>Vaginal Transluminal Endoscopic Sacrocolpopexy: A Minimal Invasive Approach for Pelvic Organ Prolapse</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Lutfi Kirdar Kartal Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr. Lutfi Kirdar Kartal 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>
        This study aims to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal&#xD;
        hysterectomy, focusing on perioperative and early postoperative results. The impact of&#xD;
        V-NOTES sacrocolpopexy on patients' quality of life is investigated using validated&#xD;
        assessment tools. Additionally, operative time, complications, pain scores were assessed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who presented to the obstetrics and gynecology outpatient clinic with complaints&#xD;
        related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q&#xD;
        classification, were between 45 and 79 years old, had no contraindications for&#xD;
        pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES&#xD;
        and gave written informed consent were included in the study. Demographic data, age, medical&#xD;
        and surgical history, body mass index (BMI), operation time, preoperative and postoperative&#xD;
        haemoglobin levels, perioperative complications and length of hospital stay were collected.&#xD;
        Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after&#xD;
        surgery. Quality of life was evaluated before and 1 month after surgery with the&#xD;
        Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress&#xD;
        Inventory (PFDI-20).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2021</start_date>
    <completion_date type="Actual">May 1, 2022</completion_date>
    <primary_completion_date type="Actual">April 1, 2022</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>The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding daily activities and emotional health</measure>
      <time_frame>1 month</time_frame>
      <description>The impact of pelvic floor function on daily activities and emotional health of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7). This study aimed to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding level of discomfort</measure>
      <time_frame>1 month</time_frame>
      <description>The level of discomfort associated with symptoms was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7). This study aimed to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">11</enrollment>
    <condition>Pelvic Organ Prolapse</condition>
    <arm_group>
      <arm_group_label>V NOTES Sacrocolpopexy arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>V-NOTES sacrocolpopexy was performed who met the eligibility criteria and gave written informed consent. Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after surgery. Quality of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>V NOTES Sacrocolpopexy</intervention_name>
      <description>The procedure involved a single-port laparoscopic surgery through the vaginal route, aiming to restore pelvic floor function by suspending the vagina to the anterior longitudinal ligament. The surgical approach differs from conventional methods, as these procedures are conducted through abdominal or vaginal routes without the aid of laparoscopic cameras, However, in our approach, we uniquely combine the widely acknowledged gold standard sacrocolpopexy procedure using vaginal route with laparoscopic camera assistance. No experimental drugs or devices were employed; only the surgical approach was modified.</description>
      <arm_group_label>V NOTES Sacrocolpopexy arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who presented to the obstetrics and gynecology outpatient clinic with&#xD;
               complaints related to pelvic organ prolapse, had stage III or IV prolapse according to&#xD;
               POP-Q classification, were between 45 and 79 years old, had no contraindications for&#xD;
               pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal&#xD;
               NOTES were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with previous pelvic inflammatory disease, deep endometriosis, severe pelvic&#xD;
               adhesions, and patients who are at risk of gynecological malignancy and are not&#xD;
               suitable for transvaginal surgery were not included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elif Gundogdu, M.D.Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kartal Dr. Lutfi Kirdar City Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kartal Dr. Lutfi Kirdar City Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Kartal</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dr. Lutfi Kirdar Kartal Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Elif Cansu Gundogdu</investigator_full_name>
      <investigator_title>Specialist doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prolapse</mesh_term>
      <mesh_term>Pelvic Organ Prolapse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004089
  org study id: 2022/514/222/30
  nct id: NCT06004089
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal
        hysterectomy, focusing on perioperative and early postoperative results. The impact of
        V-NOTES sacrocolpopexy on patients' quality of life is investigated using validated
        assessment tools. Additionally, operative time, complications, pain scores were assessed.
  Patients who presented to the obstetrics and gynecology outpatient clinic with complaints
        related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q
        classification, were between 45 and 79 years old, had no contraindications for
        pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES
        and gave written informed consent were included in the study. Demographic data, age, medical
        and surgical history, body mass index (BMI), operation time, preoperative and postoperative
        haemoglobin levels, perioperative complications and length of hospital stay were collected.
        Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after
        surgery. Quality of life was evaluated before and 1 month after surgery with the
        Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress
        Inventory (PFDI-20).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding daily activities and emotional health
  time frame: 1 month
  description: The impact of pelvic floor function on daily activities and emotional health of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7). This study aimed to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results.
  measure: The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding level of discomfort
  time frame: 1 month
  description: The level of discomfort associated with symptoms was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7). This study aimed to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results.
  arm group label: V NOTES Sacrocolpopexy arm
  arm group type: Experimental
  description: V-NOTES sacrocolpopexy was performed who met the eligibility criteria and gave written informed consent. Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after surgery. Quality of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20).
  intervention type: Procedure
  intervention name: V NOTES Sacrocolpopexy
  description: The procedure involved a single-port laparoscopic surgery through the vaginal route, aiming to restore pelvic floor function by suspending the vagina to the anterior longitudinal ligament. The surgical approach differs from conventional methods, as these procedures are conducted through abdominal or vaginal routes without the aid of laparoscopic cameras, However, in our approach, we uniquely combine the widely acknowledged gold standard sacrocolpopexy procedure using vaginal route with laparoscopic camera assistance. No experimental drugs or devices were employed; only the surgical approach was modified.
  arm group label: V NOTES Sacrocolpopexy arm
  criteria: 
  gender: Female
  minimum age: 45 Years
  maximum age: 79 Years
  healthy volunteers: No
  last name: Elif Gundogdu, M.D.Dr
  role: Principal Investigator
  affiliation: Kartal Dr. Lutfi Kirdar City Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital
  investigator full name: Elif Cansu Gundogdu
  investigator title: Specialist doctor
  mesh term: Prolapse
  mesh term: Pelvic Organ Prolapse
  sharing ipd: No