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/NCT05975762</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-09MS</org_study_id>
      <nct_id>NCT05975762</nct_id>
    </id_info>
    <brief_title>Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital</brief_title>
    <official_title>Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        The ribs are rigid and flexible structures that make up the chest skeleton and are a set of&#xD;
        twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% [1].&#xD;
  &#xD;
        Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often&#xD;
        on the midaxillary line. In ( 1st&amp;2nd) ribs fractures subclavian vessels and brachial plexus&#xD;
        damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs&#xD;
        injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are&#xD;
        rare because the ribs are more flexible (floating).&#xD;
  &#xD;
        Pain is the most important symptom indicating rib fracture, and it usually increases with&#xD;
        coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever&#xD;
        tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of&#xD;
        the sharp end of the broken rib causing lung parenchymal damage[2].&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>mechanical ventilation</measure>
      <time_frame>1 year</time_frame>
      <description>the need and duration of mechanical ventilation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>thoracic pain</measure>
      <time_frame>1 year</time_frame>
      <description>measure severity of pain using pain scale 0 to10.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Multiple Fractures of Ribs</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>surgical fixation group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>conservation group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>surgical rib fixation</intervention_name>
      <description>open reduction and internal rib fixation</description>
      <arm_group_label>intervention group</arm_group_label>
      <other_name>open reduction and internal fixation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  multiple fractured ribs pre ventilation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hossam Hassan, resident</last_name>
      <phone>01147502309</phone>
      <email>hossamhassan@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayman Abd Al-gafar, professor</last_name>
      <phone>01009899090</phone>
    </overall_contact_backup>
    <reference>
      <citation>Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3.</citation>
      <PMID>30442372</PMID>
    </reference>
    <reference>
      <citation>Schuurmans J, Goslings JC, Schepers T. Operative management versus non-operative management of rib fractures in flail chest injuries: a systematic review. Eur J Trauma Emerg Surg. 2017 Apr;43(2):163-168. doi: 10.1007/s00068-016-0721-2. Epub 2016 Aug 29.</citation>
      <PMID>27572897</PMID>
    </reference>
    <reference>
      <citation>Beks RB, Peek J, de Jong MB, Wessem KJP, Oner CF, Hietbrink F, Leenen LPH, Groenwold RHH, Houwert RM. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed. A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):631-644. doi: 10.1007/s00068-018-1020-x. Epub 2018 Oct 1.</citation>
      <PMID>30276722</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Hossam Hassan Sayed</investigator_full_name>
      <investigator_title>resident at cardiothoracic department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Multiple</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05975762
  org study id: Soh-Med-23-07-09MS
  nct id: NCT05975762
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The ribs are rigid and flexible structures that make up the chest skeleton and are a set of
        twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% [1].
  
        Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often
        on the midaxillary line. In ( 1st&2nd) ribs fractures subclavian vessels and brachial plexus
        damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs
        injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are
        rare because the ribs are more flexible (floating).
  
        Pain is the most important symptom indicating rib fracture, and it usually increases with
        coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever
        tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of
        the sharp end of the broken rib causing lung parenchymal damage[2].
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: mechanical ventilation
  time frame: 1 year
  description: the need and duration of mechanical ventilation
  measure: thoracic pain
  time frame: 1 year
  description: measure severity of pain using pain scale 0 to10.
  arm group label: intervention group
  arm group type: Active Comparator
  description: surgical fixation group
  arm group label: control group
  arm group type: No Intervention
  description: conservation group
  intervention type: Procedure
  intervention name: surgical rib fixation
  description: open reduction and internal rib fixation
  arm group label: intervention group
  other name: open reduction and internal fixation
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Hossam Hassan, resident
  phone: 01147502309
  email: hossamhassan@med.sohag.edu.eg
  last name: Ayman Abd Al-gafar, professor
  phone: 01009899090
  citation: Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3.
  PMID: 30442372
  citation: Schuurmans J, Goslings JC, Schepers T. Operative management versus non-operative management of rib fractures in flail chest injuries: a systematic review. Eur J Trauma Emerg Surg. 2017 Apr;43(2):163-168. doi: 10.1007/s00068-016-0721-2. Epub 2016 Aug 29.
  PMID: 27572897
  citation: Beks RB, Peek J, de Jong MB, Wessem KJP, Oner CF, Hietbrink F, Leenen LPH, Groenwold RHH, Houwert RM. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed. A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):631-644. doi: 10.1007/s00068-018-1020-x. Epub 2018 Oct 1.
  PMID: 30276722
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Hossam Hassan Sayed
  investigator title: resident at cardiothoracic department
  mesh term: Fractures, Multiple
  sharing ipd: Undecided