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/NCT06029101</url>
    </required_header>
    <id_info>
      <org_study_id>Chiari I surgical treatment</org_study_id>
      <nct_id>NCT06029101</nct_id>
    </id_info>
    <brief_title>Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes</brief_title>
    <official_title>Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of&#xD;
        Neurosurgery Assiut University Hospital .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chiari malformation is a group of craniocervical malformations involving the brain stem,&#xD;
        cerebellum, upper spinal cord, and surrounding bony structure, encompassing a series of&#xD;
        hindbrain herniation symptoms. The Austrian pathologist Hans Chiari ﬁrst described the&#xD;
        malformation in 1891 and such abnormality is frequently identiﬁed in both young adult and&#xD;
        pediatric patients.&#xD;
  &#xD;
        There are four main types of chiari malformations with other subtypes. Chiari I malformation&#xD;
        (CIM), in which the caudal poles of the cerebellar tonsils extend into the upper cervical&#xD;
        spinal canal, is a common clinical type. Common clinical symptoms, including headache,&#xD;
        altered sensation, weakness, dysphagia, sleep apnea.&#xD;
  &#xD;
        Between 70% and 80% of patients with CIM have accompanying syringomyelia. Surgical treatment&#xD;
        is widely accepted and is the only treatment chosen for symptomatic patients with Chiari&#xD;
        malformations.&#xD;
  &#xD;
        The aim of this study is to elucidate the most favorable procedures for CIM in terms of&#xD;
        radiological and clinical outcomes.&#xD;
  &#xD;
        Independent and dependent variables will be identiﬁed for analysis. The independent variables&#xD;
        will include patient diagnosis, surgical techniques, patient age, patient chronic diseases&#xD;
        and identified dependent variables including improvement of symptoms and signs, rates of&#xD;
        intraoperative and postoperative adverse events, and perioperative mortality.&#xD;
  &#xD;
        Different surgical modalities will be applied ,examples include bony decompression with or&#xD;
        without duraplasty with the possibility of cerebellar tonsils resection (RT) .&#xD;
  &#xD;
        Common complications include meningitis, CSF leak, pseudomeningocele, hydrocephalus,&#xD;
        respiratory failure, hemorrhage, craniocervical instability, and/or death.&#xD;
  &#xD;
        The outcome will be measured by reduction / increase of symptoms and signs using the Chicago&#xD;
        Chiari outcome scale (CCOS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .</measure>
      <time_frame>4 weeks postoperative</time_frame>
      <description>using chicago chiari outcome score The Chicago Chiari Outcome Scale (CCOS) uses 4 postoperative outcome categories (pain, nonpain symptoms, functionality, and complications) graded 1 to 4 for a total possible score of 16 , when the score is higher ,it means better outcome. pain for example will be measured by Visual Analog Score for pain.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Chiari Malformation, Type 1</condition>
    <arm_group>
      <arm_group_label>chiari I malformation patients undergoing craniectomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>modalities and outcomes of surgical treatment of chiari I malformation patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>posterior fossa craniectomy with or without duraplasty</intervention_name>
      <description>craniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils.</description>
      <arm_group_label>chiari I malformation patients undergoing craniectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chiari I Malformation patients who suffer from clinical symptoms and radiological&#xD;
               manifestations.&#xD;
  &#xD;
            -  Patients fit for surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other types of Chiari malformations&#xD;
  &#xD;
            -  Patients with multilevel cervical disc herniation .&#xD;
  &#xD;
            -  Patients with segmental instability .&#xD;
  &#xD;
            -  Patients unfit for surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed Taghian, professor</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmed Abdallah, Ass. prof</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ismail Taha, lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed Hamdy Hussein, demonstrator</last_name>
      <phone>01103960297 - 01020836040</phone>
      <email>ahmedhamdyhussein@med.nvu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ismail Taha, lecturer</last_name>
      <phone>01006268779</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Assiut University</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Shamji MF, Ventureyra EC, Baronia B, Nzau M, Vassilyadi M. Classification of symptomatic Chiari I malformation to guide surgical strategy. Can J Neurol Sci. 2010 Jul;37(4):482-7. doi: 10.1017/s0317167100010507.</citation>
      <PMID>20724256</PMID>
    </reference>
    <reference>
      <citation>2. Meadows J, Guarnieri M, Miller K, Haroun R, Kraut M, Carson BS. Type I Chiari malformation: a review of the literature. Neurosurg Q. 2001;11: 220-229.</citation>
    </reference>
    <reference>
      <citation>Hankinson T, Tubbs RS, Wellons JC. Duraplasty or not? An evidence-based review of the pediatric Chiari I malformation. Childs Nerv Syst. 2011 Jan;27(1):35-40. doi: 10.1007/s00381-010-1295-7. Epub 2010 Oct 2.</citation>
      <PMID>20890606</PMID>
    </reference>
    <reference>
      <citation>Dones J, De Jesus O, Colen CB, Toledo MM, Delgado M. Clinical outcomes in patients with Chiari I malformation: a review of 27 cases. Surg Neurol. 2003 Aug;60(2):142-7; discussion 147-8. doi: 10.1016/s0090-3019(03)00131-9.</citation>
      <PMID>12900124</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Ahmed Hamdy Hussein</investigator_full_name>
      <investigator_title>demonistrator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arnold-Chiari Malformation</mesh_term>
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <!-- 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/NCT06029101
  org study id: Chiari I surgical treatment
  nct id: NCT06029101
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of
        Neurosurgery Assiut University Hospital .
  Chiari malformation is a group of craniocervical malformations involving the brain stem,
        cerebellum, upper spinal cord, and surrounding bony structure, encompassing a series of
        hindbrain herniation symptoms. The Austrian pathologist Hans Chiari ﬁrst described the
        malformation in 1891 and such abnormality is frequently identiﬁed in both young adult and
        pediatric patients.
  
        There are four main types of chiari malformations with other subtypes. Chiari I malformation
        (CIM), in which the caudal poles of the cerebellar tonsils extend into the upper cervical
        spinal canal, is a common clinical type. Common clinical symptoms, including headache,
        altered sensation, weakness, dysphagia, sleep apnea.
  
        Between 70% and 80% of patients with CIM have accompanying syringomyelia. Surgical treatment
        is widely accepted and is the only treatment chosen for symptomatic patients with Chiari
        malformations.
  
        The aim of this study is to elucidate the most favorable procedures for CIM in terms of
        radiological and clinical outcomes.
  
        Independent and dependent variables will be identiﬁed for analysis. The independent variables
        will include patient diagnosis, surgical techniques, patient age, patient chronic diseases
        and identified dependent variables including improvement of symptoms and signs, rates of
        intraoperative and postoperative adverse events, and perioperative mortality.
  
        Different surgical modalities will be applied ,examples include bony decompression with or
        without duraplasty with the possibility of cerebellar tonsils resection (RT) .
  
        Common complications include meningitis, CSF leak, pseudomeningocele, hydrocephalus,
        respiratory failure, hemorrhage, craniocervical instability, and/or death.
  
        The outcome will be measured by reduction / increase of symptoms and signs using the Chicago
        Chiari outcome scale (CCOS).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .
  time frame: 4 weeks postoperative
  description: using chicago chiari outcome score The Chicago Chiari Outcome Scale (CCOS) uses 4 postoperative outcome categories (pain, nonpain symptoms, functionality, and complications) graded 1 to 4 for a total possible score of 16 , when the score is higher ,it means better outcome. pain for example will be measured by Visual Analog Score for pain.
  arm group label: chiari I malformation patients undergoing craniectomy
  arm group type: Experimental
  description: modalities and outcomes of surgical treatment of chiari I malformation patients
  intervention type: Procedure
  intervention name: posterior fossa craniectomy with or without duraplasty
  description: craniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils.
  arm group label: chiari I malformation patients undergoing craniectomy
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mohamed Taghian, professor
  role: Study Chair
  affiliation: Assiut University
  last name: Ahmed Abdallah, Ass. prof
  role: Study Director
  affiliation: Assiut University
  last name: Ismail Taha, lecturer
  role: Study Director
  affiliation: Assiut University
  last name: Ahmed Hamdy Hussein, demonstrator
  phone: 01103960297 - 01020836040
  email: ahmedhamdyhussein@med.nvu.edu.eg
  last name: Ismail Taha, lecturer
  phone: 01006268779
  facility: 
  status: Recruiting
  country: Egypt
  citation: Shamji MF, Ventureyra EC, Baronia B, Nzau M, Vassilyadi M. Classification of symptomatic Chiari I malformation to guide surgical strategy. Can J Neurol Sci. 2010 Jul;37(4):482-7. doi: 10.1017/s0317167100010507.
  PMID: 20724256
  citation: 2. Meadows J, Guarnieri M, Miller K, Haroun R, Kraut M, Carson BS. Type I Chiari malformation: a review of the literature. Neurosurg Q. 2001;11: 220-229.
  citation: Hankinson T, Tubbs RS, Wellons JC. Duraplasty or not? An evidence-based review of the pediatric Chiari I malformation. Childs Nerv Syst. 2011 Jan;27(1):35-40. doi: 10.1007/s00381-010-1295-7. Epub 2010 Oct 2.
  PMID: 20890606
  citation: Dones J, De Jesus O, Colen CB, Toledo MM, Delgado M. Clinical outcomes in patients with Chiari I malformation: a review of 27 cases. Surg Neurol. 2003 Aug;60(2):142-7; discussion 147-8. doi: 10.1016/s0090-3019(03)00131-9.
  PMID: 12900124
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Ahmed Hamdy Hussein
  investigator title: demonistrator
  mesh term: Arnold-Chiari Malformation
  mesh term: Congenital Abnormalities