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/NCT05973045</url>
    </required_header>
    <id_info>
      <org_study_id>617</org_study_id>
      <nct_id>NCT05973045</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy</brief_title>
    <official_title>Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ege 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>
        Minimally invasive applications are seen as the gold standard in today's gynecology practice&#xD;
        and are frequently preferred by both patients and physicians. Less pain, shorter hospital&#xD;
        stays, and better cosmetic results brought about by minimally invasive applications further&#xD;
        increase their preference. One of these approaches is hysteroscopic interventions. Although&#xD;
        hysteroscopy is a well-defined method, current research has focused on further reduction of&#xD;
        pain. One of these methods is to warm the distention media at body temperature. theTaim of&#xD;
        this study was to examine the effect of distention medium temperature on image quality,&#xD;
        hyponatremia risk, and post-operative pain in operative hysteroscopy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Minimally invasive applications are seen as the gold standard in today's gynecology practice&#xD;
        and are frequently preferred by both patients and physicians. Less pain, shorter hospital&#xD;
        stays, and better cosmetic results brought about by minimally invasive applications further&#xD;
        increase their preference. One of these approaches is hysteroscopic interventions. Although&#xD;
        hysteroscopy is a well-defined method, current research has focused on further reduction of&#xD;
        pain. One of these methods is to warm the distention media at body temperature.&#xD;
  &#xD;
        The optimum distention medium temperature has not been determined in the &quot;Best Practice in&#xD;
        Outpatient Hysteroscopy Green Top Guideline&quot; organized by The Royal College of Obstetricians&#xD;
        and Gynecologists and &quot;Guideline on Management of Fluid Distension Media in Operative&#xD;
        Hysteroscopy&quot; organized by the European Society of Gynecological Endoscopy (1,2). In routine&#xD;
        practice, some physicians use distention fluid at room temperature, while others use it by&#xD;
        warming it at body temperature. It is known that colder fluids cause irregular contractions&#xD;
        in the uterus (3). In prospective studies, the effects of heating distention media at body&#xD;
        temperature on pain were reported inconsistently (3,4). As clear data could not be obtained,&#xD;
        the risk of further intravasation and hyponatremia that may occur with the image quality and,&#xD;
        more importantly, the heating of the fluid was ignored. But; Freitas Fonseca et al. In his in&#xD;
        vitro study in Brazil, it was shown by theoretical calculations that heating hysteroscopy&#xD;
        irrigation fluids from 270C to 370C increased intravasation by 53%.&#xD;
  &#xD;
        In light of the literature, and based on the ideas and possible risks in question, the aim of&#xD;
        this study was to examine the effect of distention medium temperature on image quality,&#xD;
        hyponatremia risk, and post-operative pain in operative hysteroscopy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>
      <intervention_model_description>Prospective Randomized Controlled Clinical Study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Post-operative pain</measure>
      <time_frame>3 hours</time_frame>
      <description>Post operative pain will evalute with numeric pain rating scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post operavite Na Value</measure>
      <time_frame>1 minute</time_frame>
      <description>Post-operative blood Na value will be checked.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">244</enrollment>
    <condition>Post-operative Pain</condition>
    <arm_group>
      <arm_group_label>24 Centigrade Degree</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Operative hysteroscopy will be performed at room temperature distention medium.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>37 Centigrade Degree</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Operative hysteroscopy will be performed using a heated distention medium.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Operative Hysteroscopy 24 Centigrade Degree</intervention_name>
      <description>Operative hysteroscopy will be performed at room temperature distention medium.</description>
      <arm_group_label>24 Centigrade Degree</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Operative Hysteroscopy 37 Centigrade Degree</intervention_name>
      <description>Operative hysteroscopy will be performed using a heated distention medium.</description>
      <arm_group_label>37 Centigrade Degree</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be planned for operative hysteroscopy due to an endometrial polyp or type 0-1 myoma&#xD;
               in the range of 2-3 cm&#xD;
  &#xD;
            -  Having a vaginal delivery at least once before&#xD;
  &#xD;
            -  Ability to communicate adequately in Turkish or English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Active vaginal, and cervical infection&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sabahattin A Ari, Asst. Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Izmir Bakircay University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sabahattin A Ari, Asst. Prof.</last_name>
      <phone>+905547139994</phone>
      <email>s.anil.ari.md@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Bakircay University</investigator_affiliation>
      <investigator_full_name>Sabahattin Anıl Arı</investigator_full_name>
      <investigator_title>Asst. Prof.</investigator_title>
    </responsible_party>
    <keyword>hysteroscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyponatremia</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be published.</ipd_description>
    </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/NCT05973045
  org study id: 617
  nct id: NCT05973045
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Minimally invasive applications are seen as the gold standard in today's gynecology practice
        and are frequently preferred by both patients and physicians. Less pain, shorter hospital
        stays, and better cosmetic results brought about by minimally invasive applications further
        increase their preference. One of these approaches is hysteroscopic interventions. Although
        hysteroscopy is a well-defined method, current research has focused on further reduction of
        pain. One of these methods is to warm the distention media at body temperature. theTaim of
        this study was to examine the effect of distention medium temperature on image quality,
        hyponatremia risk, and post-operative pain in operative hysteroscopy.
  Minimally invasive applications are seen as the gold standard in today's gynecology practice
        and are frequently preferred by both patients and physicians. Less pain, shorter hospital
        stays, and better cosmetic results brought about by minimally invasive applications further
        increase their preference. One of these approaches is hysteroscopic interventions. Although
        hysteroscopy is a well-defined method, current research has focused on further reduction of
        pain. One of these methods is to warm the distention media at body temperature.
  
        The optimum distention medium temperature has not been determined in the "Best Practice in
        Outpatient Hysteroscopy Green Top Guideline" organized by The Royal College of Obstetricians
        and Gynecologists and "Guideline on Management of Fluid Distension Media in Operative
        Hysteroscopy" organized by the European Society of Gynecological Endoscopy (1,2). In routine
        practice, some physicians use distention fluid at room temperature, while others use it by
        warming it at body temperature. It is known that colder fluids cause irregular contractions
        in the uterus (3). In prospective studies, the effects of heating distention media at body
        temperature on pain were reported inconsistently (3,4). As clear data could not be obtained,
        the risk of further intravasation and hyponatremia that may occur with the image quality and,
        more importantly, the heating of the fluid was ignored. But; Freitas Fonseca et al. In his in
        vitro study in Brazil, it was shown by theoretical calculations that heating hysteroscopy
        irrigation fluids from 270C to 370C increased intravasation by 53%.
  
        In light of the literature, and based on the ideas and possible risks in question, the aim of
        this study was to examine the effect of distention medium temperature on image quality,
        hyponatremia risk, and post-operative pain in operative hysteroscopy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective Randomized Controlled Clinical Study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Post-operative pain
  time frame: 3 hours
  description: Post operative pain will evalute with numeric pain rating scale
  measure: Post operavite Na Value
  time frame: 1 minute
  description: Post-operative blood Na value will be checked.
  arm group label: 24 Centigrade Degree
  arm group type: Active Comparator
  description: Operative hysteroscopy will be performed at room temperature distention medium.
  arm group label: 37 Centigrade Degree
  arm group type: Active Comparator
  description: Operative hysteroscopy will be performed using a heated distention medium.
  intervention type: Procedure
  intervention name: Operative Hysteroscopy 24 Centigrade Degree
  description: Operative hysteroscopy will be performed at room temperature distention medium.
  arm group label: 24 Centigrade Degree
  intervention type: Procedure
  intervention name: Operative Hysteroscopy 37 Centigrade Degree
  description: Operative hysteroscopy will be performed using a heated distention medium.
  arm group label: 37 Centigrade Degree
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Sabahattin A Ari, Asst. Prof.
  role: Principal Investigator
  affiliation: Izmir Bakircay University
  last name: Sabahattin A Ari, Asst. Prof.
  phone: +905547139994
  email: s.anil.ari.md@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Izmir Bakircay University
  investigator full name: Sabahattin Anıl Arı
  investigator title: Asst. Prof.
  mesh term: Hyponatremia
  mesh term: Pain, Postoperative
  sharing ipd: No
  ipd description: IPD will not be published.