<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/NCT02976649</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU R 19/2016</org_study_id>
    <nct_id>NCT02976649</nct_id>
  </id_info>
  <brief_title>Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery</brief_title>
  <official_title>Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to propose a multi-dimensional score to predict those patients&#xD;
      undergoing bariatric surgeries who will be in need for postoperative ICU admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-dimensional score of 7 risk factors was proposed which may help in identifying&#xD;
      morbidly obese patients undergoing bariatric surgeries who will need admission to a critical&#xD;
      care unit postoperatively for follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission</measure>
    <time_frame>Through study completion, an average of six months.</time_frame>
  </primary_outcome>
  <enrollment type="Actual">111</enrollment>
  <condition>Bariatric Surgery Procedures</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Morbid obese patients who have been operated upon for either laparoscopic gastric sleeve or&#xD;
        laparoscopic gastric bypass.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who have been operated upon for either laparoscopic gastric sleeve or&#xD;
             laparoscopic gastric bypass during the period from January to June 2016.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded in case of postoperative surgical complications, conversion to&#xD;
             open surgery or in case of redo.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walid H. Nofal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology department, Faculty of Medicine, Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Walid Nofal</investigator_full_name>
    <investigator_title>Lecturer of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Morbid obesity</keyword>
  <keyword>Bariatric surgery</keyword>
  <keyword>Multi-dimensional score</keyword>
  <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/NCT02976649
org study id: FMASU R 19/2016
nct id: NCT02976649
lead sponsor: 
has dmc: No
The purpose of this study is to propose a multi-dimensional score to predict those patients
      undergoing bariatric surgeries who will be in need for postoperative ICU admission.
A multi-dimensional score of 7 risk factors was proposed which may help in identifying
      morbidly obese patients undergoing bariatric surgeries who will need admission to a critical
      care unit postoperatively for follow up.
observational model: Cohort
time perspective: Retrospective
measure: Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission
time frame: Through study completion, an average of six months.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Walid H. Nofal, MD
role: Principal Investigator
affiliation: Anesthesiology department, Faculty of Medicine, Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Walid Nofal
investigator title: Lecturer of Anesthesiology
sharing ipd: Undecided