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/NCT06014203</url>
    </required_header>
    <id_info>
      <org_study_id>Iayas5</org_study_id>
      <nct_id>NCT06014203</nct_id>
    </id_info>
    <brief_title>Examination of Edema After Arthroscopic Shoulder Surgery</brief_title>
    <official_title>Examination of Edema After Arthroscopic Shoulder Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi 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>
        Our aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair&#xD;
        and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the&#xD;
        joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline&#xD;
        fluid is injected into the joint, depending on the duration of the surgery. The given fluid&#xD;
        accumulates out of the joint in relation to the duration of the surgery and the amount of&#xD;
        fluid given. In this study, our aim is to examine how much the extra-articular fluid collects&#xD;
        under the skin of the upper extremity and trunk, and the change in the amount of fluid 24&#xD;
        hours after surgery. Examination of the amount of subcutaneous fluid may help to better&#xD;
        understand the postoperative complications such as edema, carpal tunnel syndrome, compartment&#xD;
        syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are&#xD;
        exposed to and its relationship with the duration of surgery can help us determine the safe&#xD;
        discharge time.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 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>Edema</measure>
      <time_frame>3 months</time_frame>
      <description>After the MoistureMeterD Compact local edema measuring device is placed perpendicular to the area to be measured, it will be held for 3 seconds and the percent moisture value will be recorded. 3 measurements will be made for each region. The average of the 3 measurements will be used in the statistical analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgery time</measure>
      <time_frame>3 months</time_frame>
      <description>The duration of each operation will be recorded in minutes by the surgeon performing the operation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of the saline</measure>
      <time_frame>3 months</time_frame>
      <description>The amount of saline fluid used in each operation will be recorded in liters by the surgeon performing the operation.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Edema</condition>
    <condition>Arthroscopy</condition>
    <condition>Shoulder</condition>
    <arm_group>
      <arm_group_label>Patients undergoing shoulder arthroscopy surgery</arm_group_label>
      <description>Patients who underwent arthroscopic shoulder surgery by a single surgeon at Gazi Hospital Department of Orthopedics and Traumatology (rotator cuff repair, slap, bankart repair)</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Edema measurement</intervention_name>
      <description>Subcutaneous fluid measurements will be made 3 times in total, before the surgery, immediately after the surgery and 24 hours after the surgery. Measurements will be made with the MoistureMeterD Compact local edema measuring device.&#xD;
  Points to be measured:&#xD;
  Midpoint of the upper trapezius muscle&#xD;
  5 cm distal to anterior acromion&#xD;
  5cm distal to lateral acromion&#xD;
  5cm distal to posterior acromion&#xD;
  3cm medial to the axilla&#xD;
  Anterior cubital fossa&#xD;
  Carpal tunnel</description>
      <arm_group_label>Patients undergoing shoulder arthroscopy surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital,&#xD;
          Department of Orthopedics and Traumatology&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Arthroscopic shoulder surgery planned&#xD;
  &#xD;
            -  18-65 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Frozen/stiff shoulder&#xD;
  &#xD;
            -  Metabolic and endocrine diseases&#xD;
  &#xD;
            -  Dermatological pathologies&#xD;
  &#xD;
            -  Hyperlaxity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ulunay Kanatlı</last_name>
      <role>Study Director</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>İnci H Ayas</last_name>
      <phone>05071740342</phone>
      <email>inciayass@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>İnci Hazal Ayas</investigator_full_name>
      <investigator_title>Research asistant (PT)</investigator_title>
    </responsible_party>
    <keyword>Edema; Shoulder arthroscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available.</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/NCT06014203
  org study id: Iayas5
  nct id: NCT06014203
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair
        and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the
        joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline
        fluid is injected into the joint, depending on the duration of the surgery. The given fluid
        accumulates out of the joint in relation to the duration of the surgery and the amount of
        fluid given. In this study, our aim is to examine how much the extra-articular fluid collects
        under the skin of the upper extremity and trunk, and the change in the amount of fluid 24
        hours after surgery. Examination of the amount of subcutaneous fluid may help to better
        understand the postoperative complications such as edema, carpal tunnel syndrome, compartment
        syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are
        exposed to and its relationship with the duration of surgery can help us determine the safe
        discharge time.
  observational model: Cohort
  time perspective: Prospective
  measure: Edema
  time frame: 3 months
  description: After the MoistureMeterD Compact local edema measuring device is placed perpendicular to the area to be measured, it will be held for 3 seconds and the percent moisture value will be recorded. 3 measurements will be made for each region. The average of the 3 measurements will be used in the statistical analysis.
  measure: Surgery time
  time frame: 3 months
  description: The duration of each operation will be recorded in minutes by the surgeon performing the operation.
  measure: Amount of the saline
  time frame: 3 months
  description: The amount of saline fluid used in each operation will be recorded in liters by the surgeon performing the operation.
  arm group label: Patients undergoing shoulder arthroscopy surgery
  description: Patients who underwent arthroscopic shoulder surgery by a single surgeon at Gazi Hospital Department of Orthopedics and Traumatology (rotator cuff repair, slap, bankart repair)
  intervention type: Diagnostic Test
  intervention name: Edema measurement
  description: Subcutaneous fluid measurements will be made 3 times in total, before the surgery, immediately after the surgery and 24 hours after the surgery. Measurements will be made with the MoistureMeterD Compact local edema measuring device.
  Points to be measured:
  Midpoint of the upper trapezius muscle
  5 cm distal to anterior acromion
  5cm distal to lateral acromion
  5cm distal to posterior acromion
  3cm medial to the axilla
  Anterior cubital fossa
  Carpal tunnel
  arm group label: Patients undergoing shoulder arthroscopy surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Ulunay Kanatlı
  role: Study Director
  affiliation: Gazi University
  last name: İnci H Ayas
  phone: 05071740342
  email: inciayass@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: İnci Hazal Ayas
  investigator title: Research asistant (PT)
  mesh term: Edema
  sharing ipd: No
  ipd description: There is not a plan to make IPD available.