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/NCT05994560</url>
    </required_header>
    <id_info>
      <org_study_id>324/19</org_study_id>
      <nct_id>NCT05994560</nct_id>
    </id_info>
    <brief_title>The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy</brief_title>
    <official_title>Valor de la oclusión Temporal de Las Arterias Uterinas en la miomectomía Por Laparoscopia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</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>
        The objective of this study is to determine whether patients undergoing laparoscopic&#xD;
        myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments using&#xD;
        clips experience a decrease in blood loss during surgery compared to patients who undergo&#xD;
        laparoscopic myomectomy without clips.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        Uterine fibroids are the most common benign tumors originating in the smooth muscle of the&#xD;
        female genital tract. They occur in approximately 70% of women of middle age. Often, they&#xD;
        cause abnormal uterine bleeding, pain, pelvic pressure, urinary and intestinal symptoms,&#xD;
        and/or pregnancy complications. However, many fibroids are small and asymptomatic. About 25%&#xD;
        of white women and 50% of black women will develop symptomatic fibroids. Fibroids are more&#xD;
        common among overweight or obese women. Potential protective factors for fibroid occurrence&#xD;
        are pregnancies and smoking, with a possible causal relationship, although the exact&#xD;
        mechanism is not clear.&#xD;
  &#xD;
        The treatment for women with uterine fibroids should be individualized based on their&#xD;
        symptoms, size and location of fibroids, age, the need and desire to preserve fertility or&#xD;
        the uterus, the availability of therapy, and the surgeon's experience. While hysterectomy is&#xD;
        the definitive surgical treatment for symptomatic fibroids in women who do not wish to&#xD;
        preserve fertility or their uterus, myomectomy is the treatment of choice for those with&#xD;
        unfulfilled reproductive desires or a clear desire to keep their uterus and who are not&#xD;
        suitable candidates for medical treatment.&#xD;
  &#xD;
        The surgical planning for myomectomy should be based on the location, size, and number of&#xD;
        fibroids, aided by appropriate imaging tests such as high-resolution ultrasound or magnetic&#xD;
        resonance imaging (MRI).&#xD;
  &#xD;
        Justification of the Study:&#xD;
  &#xD;
        Intraoperative bleeding is one of the most frequent complications of laparoscopic myomectomy&#xD;
        and may sometimes require transfusion. Therefore, methods that could reduce bleeding during&#xD;
        surgery have been proposed, such as temporary occlusion of the uterine arteries and&#xD;
        utero-ovarian ligaments. However, the efficacy and safety of this technique for use during&#xD;
        laparoscopic myomectomy have not been clearly investigated.&#xD;
  &#xD;
        Research Hypothesis:&#xD;
  &#xD;
        The study aims to identify the efficacy of temporary occlusion of the uterine arteries during&#xD;
        laparoscopic myomectomy.&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
        Primary Objective:&#xD;
  &#xD;
        - To compare the hemoglobin loss in g/dL (grams per deciliter) before and after surgery and&#xD;
        intraoperative blood aspirate in milliliters between two groups of patients with symptomatic&#xD;
        fibroids undergoing laparoscopic surgery, one with temporary occlusion of uterine arteries&#xD;
        and utero-ovarian ligaments using clips and the other without such occlusion.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  To compare the surgical time of each technique.&#xD;
  &#xD;
          -  To compare the need for transfusion between both groups.&#xD;
  &#xD;
          -  To compare the improvement in symptoms for which the patients undergo surgery.&#xD;
  &#xD;
          -  To compare the length of hospital stay in each group.&#xD;
  &#xD;
          -  To compare possible complications of each technique.&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        A prospective randomized longitudinal study.&#xD;
  &#xD;
        Study Subjects:&#xD;
  &#xD;
        Patients with symptomatic fibroids requiring laparoscopic surgery as treatment, from the&#xD;
        Gynecology Service of Hospital Ramón y Cajal and the HM Hospital, will be recruited. They&#xD;
        will be randomized into two groups using simple random sampling. Patients will be given&#xD;
        informed consent to participate in the study. The diagnosis of fibroids will be made through&#xD;
        abdominal and/or transvaginal gynecological ultrasound and/or MRI.&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
        - Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a&#xD;
        desire to preserve the uterus.&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          -  Patients who do not meet the inclusion criteria.&#xD;
  &#xD;
          -  Women with symptomatic fibroids who are not candidates for laparoscopic surgery and/or&#xD;
             have no desire to preserve the uterus.&#xD;
  &#xD;
          -  Patients for whom technical placement of clips during the intervention is not possible.&#xD;
  &#xD;
        Main Variables:&#xD;
  &#xD;
          -  Preoperative and postoperative hemoglobin levels measured in g/dL.&#xD;
  &#xD;
          -  Intraoperative blood aspirate in milliliters.&#xD;
  &#xD;
          -  Surgical time.&#xD;
  &#xD;
          -  Need for transfusion.&#xD;
  &#xD;
          -  Improvement in symptoms.&#xD;
  &#xD;
          -  Length of hospital stay.&#xD;
  &#xD;
          -  Complications.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
        The data will be collected from the patients' medical records and entered into a database&#xD;
        using the SPSS software (version 23.0).&#xD;
  &#xD;
        Ethical Aspects:&#xD;
  &#xD;
        The study will follow the ethical principles laid out in the Declaration of Helsinki and Good&#xD;
        Clinical Practice guidelines. Confidentiality of patient data will be maintained, and&#xD;
        patients will provide informed consent to participate in the study.&#xD;
  &#xD;
        Policy of Publications:&#xD;
  &#xD;
        The study results will be published in scientific journals and medical conferences, subject&#xD;
        to approval from the investigator and the Thesis Directors. The results will also be used as&#xD;
        the basis for the investigator's doctoral thesis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 2, 2020</start_date>
    <completion_date type="Actual">December 21, 2022</completion_date>
    <primary_completion_date type="Actual">December 21, 2022</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>Single Group Assignment</intervention_model>
      <intervention_model_description>randomized clinical tria</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood loss during surgery</measure>
      <time_frame>during the time of the surgery</time_frame>
      <description>The estimated intraoperative blood loss was calculated by measuring the amount of aspirated fluid at the end of the procedure minus the amount of fluid used for irrigation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To compare the surgical time of each technique</measure>
      <time_frame>during surgery</time_frame>
      <description>Time was recorded from the first skin incision to the last suture (minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>until 1 week</time_frame>
      <description>Days of hospital admission prior to discharge counting from the day of the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in pre and postoperative hemoglobin levels (Hemoglobin loss)</measure>
      <time_frame>up to 24 hours after surgery</time_frame>
      <description>Preoperative hemoglobin was obtained within 24 hours before surgery, and postoperative hemoglobin was collected on postoperative day 1. Hemoglobin loss expressed in g/dL (grams per deciliter) was obtained from comparing hemoglobine pre and postoperative (before and after surgery).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Uterine Myomectomy</condition>
    <arm_group>
      <arm_group_label>without temporary occlusion</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Without temporary occlusion: No occlusion of uterine or útero-ovarian ligaments during laparoscopy myomectomy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>With temporary occlusion</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Temporary occlusion of the uterine arteries and utero-ovarian ligaments during laparoscopic myomectomy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>With temporary occlusion</intervention_name>
      <description>at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed</description>
      <arm_group_label>With temporary occlusion</arm_group_label>
      <arm_group_label>without temporary occlusion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a&#xD;
               desire to preserve the uterus.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not meet the inclusion criteria.&#xD;
  &#xD;
            -  Women with symptomatic fibroids who are not candidates for laparoscopic surgery and/or&#xD;
               have no desire to preserve the uterus.&#xD;
  &#xD;
            -  Patients for whom technical placement of clips during the intervention is not&#xD;
               possible.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Enrique Moratalla Bartolomé</name>
        <address>
          <city>Madrid</city>
          <zip>28029</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</investigator_affiliation>
      <investigator_full_name>enrique moratalla bartolome</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>myomectomy</keyword>
    <keyword>temporary occlusion</keyword>
    <keyword>uerine arteries</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>February 15, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT05994560/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>February 14, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT05994560/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05994560
  org study id: 324/19
  nct id: NCT05994560
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to determine whether patients undergoing laparoscopic
        myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments using
        clips experience a decrease in blood loss during surgery compared to patients who undergo
        laparoscopic myomectomy without clips.
  Introduction:
  
        Uterine fibroids are the most common benign tumors originating in the smooth muscle of the
        female genital tract. They occur in approximately 70% of women of middle age. Often, they
        cause abnormal uterine bleeding, pain, pelvic pressure, urinary and intestinal symptoms,
        and/or pregnancy complications. However, many fibroids are small and asymptomatic. About 25%
        of white women and 50% of black women will develop symptomatic fibroids. Fibroids are more
        common among overweight or obese women. Potential protective factors for fibroid occurrence
        are pregnancies and smoking, with a possible causal relationship, although the exact
        mechanism is not clear.
  
        The treatment for women with uterine fibroids should be individualized based on their
        symptoms, size and location of fibroids, age, the need and desire to preserve fertility or
        the uterus, the availability of therapy, and the surgeon's experience. While hysterectomy is
        the definitive surgical treatment for symptomatic fibroids in women who do not wish to
        preserve fertility or their uterus, myomectomy is the treatment of choice for those with
        unfulfilled reproductive desires or a clear desire to keep their uterus and who are not
        suitable candidates for medical treatment.
  
        The surgical planning for myomectomy should be based on the location, size, and number of
        fibroids, aided by appropriate imaging tests such as high-resolution ultrasound or magnetic
        resonance imaging (MRI).
  
        Justification of the Study:
  
        Intraoperative bleeding is one of the most frequent complications of laparoscopic myomectomy
        and may sometimes require transfusion. Therefore, methods that could reduce bleeding during
        surgery have been proposed, such as temporary occlusion of the uterine arteries and
        utero-ovarian ligaments. However, the efficacy and safety of this technique for use during
        laparoscopic myomectomy have not been clearly investigated.
  
        Research Hypothesis:
  
        The study aims to identify the efficacy of temporary occlusion of the uterine arteries during
        laparoscopic myomectomy.
  
        Objectives:
  
        Primary Objective:
  
        - To compare the hemoglobin loss in g/dL (grams per deciliter) before and after surgery and
        intraoperative blood aspirate in milliliters between two groups of patients with symptomatic
        fibroids undergoing laparoscopic surgery, one with temporary occlusion of uterine arteries
        and utero-ovarian ligaments using clips and the other without such occlusion.
  
        Secondary Objectives:
  
          -  To compare the surgical time of each technique.
  
          -  To compare the need for transfusion between both groups.
  
          -  To compare the improvement in symptoms for which the patients undergo surgery.
  
          -  To compare the length of hospital stay in each group.
  
          -  To compare possible complications of each technique.
  
        Methodology:
  
        Design:
  
        A prospective randomized longitudinal study.
  
        Study Subjects:
  
        Patients with symptomatic fibroids requiring laparoscopic surgery as treatment, from the
        Gynecology Service of Hospital Ramón y Cajal and the HM Hospital, will be recruited. They
        will be randomized into two groups using simple random sampling. Patients will be given
        informed consent to participate in the study. The diagnosis of fibroids will be made through
        abdominal and/or transvaginal gynecological ultrasound and/or MRI.
  
        Inclusion Criteria:
  
        - Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a
        desire to preserve the uterus.
  
        Exclusion Criteria:
  
          -  Patients who do not meet the inclusion criteria.
  
          -  Women with symptomatic fibroids who are not candidates for laparoscopic surgery and/or
             have no desire to preserve the uterus.
  
          -  Patients for whom technical placement of clips during the intervention is not possible.
  
        Main Variables:
  
          -  Preoperative and postoperative hemoglobin levels measured in g/dL.
  
          -  Intraoperative blood aspirate in milliliters.
  
          -  Surgical time.
  
          -  Need for transfusion.
  
          -  Improvement in symptoms.
  
          -  Length of hospital stay.
  
          -  Complications.
  
        Data Collection:
  
        The data will be collected from the patients' medical records and entered into a database
        using the SPSS software (version 23.0).
  
        Ethical Aspects:
  
        The study will follow the ethical principles laid out in the Declaration of Helsinki and Good
        Clinical Practice guidelines. Confidentiality of patient data will be maintained, and
        patients will provide informed consent to participate in the study.
  
        Policy of Publications:
  
        The study results will be published in scientific journals and medical conferences, subject
        to approval from the investigator and the Thesis Directors. The results will also be used as
        the basis for the investigator's doctoral thesis.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: randomized clinical tria
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Blood loss during surgery
  time frame: during the time of the surgery
  description: The estimated intraoperative blood loss was calculated by measuring the amount of aspirated fluid at the end of the procedure minus the amount of fluid used for irrigation.
  measure: To compare the surgical time of each technique
  time frame: during surgery
  description: Time was recorded from the first skin incision to the last suture (minutes).
  measure: Length of hospital stay
  time frame: until 1 week
  description: Days of hospital admission prior to discharge counting from the day of the intervention.
  measure: Difference in pre and postoperative hemoglobin levels (Hemoglobin loss)
  time frame: up to 24 hours after surgery
  description: Preoperative hemoglobin was obtained within 24 hours before surgery, and postoperative hemoglobin was collected on postoperative day 1. Hemoglobin loss expressed in g/dL (grams per deciliter) was obtained from comparing hemoglobine pre and postoperative (before and after surgery).
  arm group label: without temporary occlusion
  arm group type: Other
  description: Without temporary occlusion: No occlusion of uterine or útero-ovarian ligaments during laparoscopy myomectomy
  arm group label: With temporary occlusion
  arm group type: Active Comparator
  description: Temporary occlusion of the uterine arteries and utero-ovarian ligaments during laparoscopic myomectomy
  intervention type: Other
  intervention name: With temporary occlusion
  description: at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed
  arm group label: With temporary occlusion
  arm group label: without temporary occlusion
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  investigator full name: enrique moratalla bartolome
  investigator title: Principal Investigator
  sharing ipd: No
  provided document: 
  provided document: 