<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/NCT04481880</url>
  </required_header>
  <id_info>
    <org_study_id>Rambam ethics number: 0019-12</org_study_id>
    <nct_id>NCT04481880</nct_id>
  </id_info>
  <brief_title>Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity</brief_title>
  <official_title>Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure&#xD;
      have not been addressed&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intra-abdominal pressure (IAP) affects cardio-respiratory hemodynamics and can be assessed&#xD;
      either directly, or by measuring gastric or urinary bladder pressure. However, in patients&#xD;
      with morbid obesity, the correlations between gastric and urinary bladder pressures with IAP&#xD;
      have not been addressed. The investigator's aim was to assess the correlations between IAP&#xD;
      and gastric and urinary bladder pressure in patients with morbid obesity, at normal and&#xD;
      elevated levels of IAP, and to examine the effects of increasing IAP and patient position on&#xD;
      hemodynamic and respiratory parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>correlation between intra-abdominal pressure and gastric pressure</measure>
    <time_frame>Early post-operative- up to 1 week post operation</time_frame>
    <description>different measurement methods</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra-abdominal pressure</measure>
    <time_frame>0-7 days post bariatric surgery</time_frame>
    <description>Correlation between measured IAP according to different measurement methods</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Morbid Obesity</condition>
  <condition>Intra-Abdominal Hypertension</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>measuring IAP and respiratory parameters</intervention_name>
    <description>Effect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult subjects with morbid obesity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  Morbid Obesity&#xD;
&#xD;
          -  candidate for bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to laparoscopy&#xD;
&#xD;
          -  Advanced COPD&#xD;
&#xD;
          -  Advanced CHF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>rambam75</investigator_full_name>
    <investigator_title>Dr. Shadi Hamoud, Deputy director, Internal medicine E</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intra-Abdominal Hypertension</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04481880
org study id: Rambam ethics number: 0019-12
nct id: NCT04481880
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure
      have not been addressed
Intra-abdominal pressure (IAP) affects cardio-respiratory hemodynamics and can be assessed
      either directly, or by measuring gastric or urinary bladder pressure. However, in patients
      with morbid obesity, the correlations between gastric and urinary bladder pressures with IAP
      have not been addressed. The investigator's aim was to assess the correlations between IAP
      and gastric and urinary bladder pressure in patients with morbid obesity, at normal and
      elevated levels of IAP, and to examine the effects of increasing IAP and patient position on
      hemodynamic and respiratory parameters.
observational model: Case-Only
time perspective: Prospective
measure: correlation between intra-abdominal pressure and gastric pressure
time frame: Early post-operative- up to 1 week post operation
description: different measurement methods
measure: Intra-abdominal pressure
time frame: 0-7 days post bariatric surgery
description: Correlation between measured IAP according to different measurement methods
intervention type: Diagnostic Test
intervention name: measuring IAP and respiratory parameters
description: Effect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: rambam75
investigator title: Dr. Shadi Hamoud, Deputy director, Internal medicine E
mesh term: Intra-Abdominal Hypertension
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: Undecided