<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/NCT01679691</url>
  </required_header>
  <id_info>
    <org_study_id>CCHE-BoneT001</org_study_id>
    <nct_id>NCT01679691</nct_id>
  </id_info>
  <brief_title>The Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Post Lower Limb Salvage Surgery</brief_title>
  <official_title>The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Cancer Hospital Egypt 57357</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Cancer Hospital Egypt 57357</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain&#xD;
      control intra and more importantly post-operative pain. It is a well-known effect of epidural&#xD;
      injections to cause a sympathetic stimulation and consequently vasodilatation in the lower&#xD;
      limb vessels.&#xD;
&#xD;
      Since epidural catheters can cause vasodilatation in lower limb vessels, they can&#xD;
      subsequently lead to increased intra and post-operative bleeding from the surgical wound.&#xD;
&#xD;
      The study will involve all patients having a bone tumor in the lower limb and subjected to&#xD;
      tumor resection and reconstruction by prosthesis.&#xD;
&#xD;
      The patient will be randomized according to the administration of epidural anesthesia into&#xD;
      two arms, an arm in which epidural anesthesia was employed and another arm in which the&#xD;
      patient was subjected only to general anesthesia and the amount of intra and postoperative&#xD;
      bleeding will be compared in both arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessment of intra-operative bleeding will be based upon weighing and counting of the blood&#xD;
      soaked dressing and the amount of blood transfusion used.&#xD;
&#xD;
      Assessment of post-operative bleeding will be based upon the amount of blood collected from&#xD;
      the suction drain and amount of blood transfusion.&#xD;
&#xD;
      All patient subjected to anticoagulant post-operative or another type of surgery other than&#xD;
      implantation of prosthesis will be excluded from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Till IRB renewal&#xD;
  </why_stopped>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the blood loss intra- and post-operative in both the contro and study groups</measure>
    <time_frame>start of surgery until removal of sucction drain</time_frame>
    <description>The amount of blood loss will be assessed using:&#xD;
Intra-operative: measurement of dressing before and after being soaked.&#xD;
Post-operative: amount of blood drainage and duration of use of the suction drain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prolongation of hospital stay</measure>
    <time_frame>the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days</time_frame>
    <description>the number of days calculated from date of surgery until discharge from hospital expected average from 5 to 7 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bone Tumor</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group in whom no epidural anesthesia will be applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>epidural anesthesia</intervention_name>
    <description>the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative</description>
    <arm_group_label>Epidural Anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lower limb bone tumor&#xD;
&#xD;
          -  reconstruction by prosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  upper limb and pelvic salvage surgery.&#xD;
&#xD;
          -  other methods of reconstruction than prosthesis&#xD;
&#xD;
          -  use of tourniquet intra-operative.&#xD;
&#xD;
          -  post-operative anticoagulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ahmed elghoneimy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Cancer Hospital Egypt 57357</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Cancer Hospital Egypt-57357</name>
      <address>
        <city>Cairo</city>
        <zip>11441</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>April 15, 2018</last_update_submitted>
  <last_update_submitted_qc>April 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01679691
org study id: CCHE-BoneT001
nct id: NCT01679691
lead sponsor: 
has dmc: Yes
Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain
      control intra and more importantly post-operative pain. It is a well-known effect of epidural
      injections to cause a sympathetic stimulation and consequently vasodilatation in the lower
      limb vessels.

      Since epidural catheters can cause vasodilatation in lower limb vessels, they can
      subsequently lead to increased intra and post-operative bleeding from the surgical wound.

      The study will involve all patients having a bone tumor in the lower limb and subjected to
      tumor resection and reconstruction by prosthesis.

      The patient will be randomized according to the administration of epidural anesthesia into
      two arms, an arm in which epidural anesthesia was employed and another arm in which the
      patient was subjected only to general anesthesia and the amount of intra and postoperative
      bleeding will be compared in both arms.
Assessment of intra-operative bleeding will be based upon weighing and counting of the blood
      soaked dressing and the amount of blood transfusion used.

      Assessment of post-operative bleeding will be based upon the amount of blood collected from
      the suction drain and amount of blood transfusion.

      All patient subjected to anticoagulant post-operative or another type of surgery other than
      implantation of prosthesis will be excluded from the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Measure the blood loss intra- and post-operative in both the contro and study groups
time frame: start of surgery until removal of sucction drain
description: The amount of blood loss will be assessed using:
Intra-operative: measurement of dressing before and after being soaked.
Post-operative: amount of blood drainage and duration of use of the suction drain.
measure: prolongation of hospital stay
time frame: the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days
description: the number of days calculated from date of surgery until discharge from hospital expected average from 5 to 7 days
arm group label: Control group
arm group type: No Intervention
description: Control group in whom no epidural anesthesia will be applied
arm group label: Epidural Anesthesia
arm group type: Active Comparator
description: the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
intervention type: Other
intervention name: epidural anesthesia
description: the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
arm group label: Epidural Anesthesia
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: ahmed elghoneimy, MD
role: Principal Investigator
affiliation: Children's Cancer Hospital Egypt 57357
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Bone Neoplasms
mesh term: Anesthetics