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/NCT05990647</url>
    </required_header>
    <id_info>
      <org_study_id>&quot;EC&quot; №1-2022</org_study_id>
      <nct_id>NCT05990647</nct_id>
    </id_info>
    <brief_title>Impact Evaluation of Incisional Hernia on Muscular and Postural Function</brief_title>
    <acronym>IHMPF-1</acronym>
    <official_title>Incisional Hernia Impact on Muscular and Postural Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tashkent state dental institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>I.M. Sechenov First Moscow State Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Pirogov Russian National Research Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov</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>
        Purpose of study is to assess perioperative functional parameters of the anterior abdominal&#xD;
        wall muscles and postural control status in patients with large and giant incisional hernias&#xD;
        in a controlled diagnostic study.&#xD;
  &#xD;
        The study involved 95 patients (100% completed) with a large or giant incisional hernia of&#xD;
        the anterior abdominal wall. The participants were divided into three groups by type of&#xD;
        hernia repair: bridged hernia repair, Rives-Stoppa procedure, or TAR technique. Perioperative&#xD;
        functional parameters of the anterior abdominal wall muscles were assessed by tension&#xD;
        dynamometry. The postural balance assessments were made by raster photostereography.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2, 2018</start_date>
    <completion_date type="Actual">May 15, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 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>Parallel Assignment</intervention_model>
      <intervention_model_description>Cohort study</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnostic accuracy</measure>
      <time_frame>1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia</time_frame>
      <description>Sensitivity and specificity</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">95</enrollment>
    <condition>Incisional Hernia</condition>
    <arm_group>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group III</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>29 patients who underwent posterior components separation with transversus abdominis release (TAR).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Dynamometric tension assessment</intervention_name>
      <description>Tension dynamometry was carried out using the &quot;Back-Check 600&quot; diagnostic complex by Dr.WOLFF® (GmbH, Germany). The dynamometric stress assessment included tasks for flexion and extension of the body. The functional assessment of the abdominal wall muscles was assessed when preparing the patient for surgery (1-10 days before AWR-abdominal wall reconstruction) and 6 months after AWR.</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_label>Group III</arm_group_label>
      <other_name>DT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Postural balance</intervention_name>
      <description>Postural balance was assessed using raster photostereography and baropodometry on the &quot;DIERS&quot; diagnostic complex by Formetric-4D (GmbH, Germany). When analyzing the topography of the optical field, muscle imbalance is revealed in the form of lateral deviation and inclination of the trunk and pelvis, as well as the values of the angle of kyphosis and lordosis. When conducting baropodometry, the level of displacement of the pressure area on the feet of patients in a static and dynamic position was assessed. Diagnosis of postural balance in patients with incisional ventral hernia was performed a few days before surgical treatment and 6 months after AWR.</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_label>Group III</arm_group_label>
      <other_name>PB</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Assessment of the hernia defect size</intervention_name>
      <description>Parameters of the hernial defect, including the volume of the hernial sac, the diameter of the hernial orifice, the ratio of hernia volume to the abdominal cavity volume, were performed using preoperative (1-10 days before AWR) multispiral computed tomography on a GE &quot;BrightSpeed 16&quot; tomograph (General Electric©, USA)</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_label>Group III</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Physical activity of patients</intervention_name>
      <description>To analyze the physical activity of patients, the measurement of the number of steps was used. The measurements of steps and the amount of distance traveled were carried out using a physical activity monitor - a fitness bracelet &quot;MiBAND&quot; (China). Measurements were taken 10 days before AWR and within 6 months after AWR.</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_label>Group III</arm_group_label>
      <other_name>PAP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  big and giant incisional hernia&#xD;
  &#xD;
            -  hernia without recurrence&#xD;
  &#xD;
            -  age 18-75&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  acute infection diseases&#xD;
  &#xD;
            -  cancer&#xD;
  &#xD;
            -  orthopedic diseases&#xD;
  &#xD;
            -  terminal status&#xD;
  &#xD;
            -  BMI&gt;39,9&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Otabek J. Eshonkhodjaev, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov</name>
        <address>
          <city>Tashkent</city>
          <zip>100100</zip>
          <country>Uzbekistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Uzbekistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov</investigator_affiliation>
      <investigator_full_name>Nikita A. Demin</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>incisional hernia</keyword>
    <keyword>tension dynamometry</keyword>
    <keyword>raster photostereography</keyword>
    <keyword>postural balance</keyword>
    <keyword>hernia repair</keyword>
    <keyword>bridging technique</keyword>
    <keyword>Rives-Stoppa</keyword>
    <keyword>TAR</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Incisional Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </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/NCT05990647
  org study id: "EC" №1-2022
  nct id: NCT05990647
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose of study is to assess perioperative functional parameters of the anterior abdominal
        wall muscles and postural control status in patients with large and giant incisional hernias
        in a controlled diagnostic study.
  
        The study involved 95 patients (100% completed) with a large or giant incisional hernia of
        the anterior abdominal wall. The participants were divided into three groups by type of
        hernia repair: bridged hernia repair, Rives-Stoppa procedure, or TAR technique. Perioperative
        functional parameters of the anterior abdominal wall muscles were assessed by tension
        dynamometry. The postural balance assessments were made by raster photostereography.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Cohort study
  primary purpose: Diagnostic
  masking: Single (Investigator)
  measure: Diagnostic accuracy
  time frame: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
  description: Sensitivity and specificity
  arm group label: Group I
  arm group type: Active Comparator
  description: 32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair.
  arm group label: Group II
  arm group type: Active Comparator
  description: 34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa
  arm group label: Group III
  arm group type: Active Comparator
  description: 29 patients who underwent posterior components separation with transversus abdominis release (TAR).
  intervention type: Diagnostic Test
  intervention name: Dynamometric tension assessment
  description: Tension dynamometry was carried out using the "Back-Check 600" diagnostic complex by Dr.WOLFF® (GmbH, Germany). The dynamometric stress assessment included tasks for flexion and extension of the body. The functional assessment of the abdominal wall muscles was assessed when preparing the patient for surgery (1-10 days before AWR-abdominal wall reconstruction) and 6 months after AWR.
  arm group label: Group I
  arm group label: Group II
  arm group label: Group III
  other name: DT
  intervention type: Diagnostic Test
  intervention name: Postural balance
  description: Postural balance was assessed using raster photostereography and baropodometry on the "DIERS" diagnostic complex by Formetric-4D (GmbH, Germany). When analyzing the topography of the optical field, muscle imbalance is revealed in the form of lateral deviation and inclination of the trunk and pelvis, as well as the values of the angle of kyphosis and lordosis. When conducting baropodometry, the level of displacement of the pressure area on the feet of patients in a static and dynamic position was assessed. Diagnosis of postural balance in patients with incisional ventral hernia was performed a few days before surgical treatment and 6 months after AWR.
  arm group label: Group I
  arm group label: Group II
  arm group label: Group III
  other name: PB
  intervention type: Diagnostic Test
  intervention name: Assessment of the hernia defect size
  description: Parameters of the hernial defect, including the volume of the hernial sac, the diameter of the hernial orifice, the ratio of hernia volume to the abdominal cavity volume, were performed using preoperative (1-10 days before AWR) multispiral computed tomography on a GE "BrightSpeed 16" tomograph (General Electric©, USA)
  arm group label: Group I
  arm group label: Group II
  arm group label: Group III
  intervention type: Diagnostic Test
  intervention name: Physical activity of patients
  description: To analyze the physical activity of patients, the measurement of the number of steps was used. The measurements of steps and the amount of distance traveled were carried out using a physical activity monitor - a fitness bracelet "MiBAND" (China). Measurements were taken 10 days before AWR and within 6 months after AWR.
  arm group label: Group I
  arm group label: Group II
  arm group label: Group III
  other name: PAP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Otabek J. Eshonkhodjaev, MD, PhD
  role: Study Chair
  affiliation: Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
  facility: 
  country: Uzbekistan
  responsible party type: Principal Investigator
  investigator affiliation: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
  investigator full name: Nikita A. Demin
  investigator title: Principal investigator
  mesh term: Hernia
  mesh term: Incisional Hernia
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)