<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/NCT02254590</url>
  </required_header>
  <id_info>
    <org_study_id>Kasr Einy</org_study_id>
    <nct_id>NCT02254590</nct_id>
  </id_info>
  <brief_title>Irrigation Endoscopic Decompression</brief_title>
  <official_title>Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate a new endoscopic technique for lumbar spinal canal decompression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      104 consecutive patients suffering of neurogenic claudication were included in the study.&#xD;
&#xD;
      Patients were operated using the irrigation endoscopic decompression technique. Mean Follow&#xD;
      up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index&#xD;
      [19] and the modified Macnab Criteria All statistical calculations were done using computer&#xD;
      programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA)&#xD;
      version 15 for Microsoft Windows&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Oswestry Disability Index</measure>
    <time_frame>24 months</time_frame>
    <description>Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Macnab criteria</measure>
    <time_frame>24 months</time_frame>
    <description>patient satisfaction, the need for medications, ability to return to activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time for ambulation</measure>
    <time_frame>72 hours</time_frame>
    <description>postoperative time required to start ambulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for hospitalization</measure>
    <time_frame>72 hours</time_frame>
    <description>postoperative hospital stay till discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS for back pain</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain intensity on scale from 0-10</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Lumbar Spinal Canal Stenosis</condition>
  <arm_group>
    <arm_group_label>IEDL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endoscopic decompression of spinal stenosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Irrigation Endoscopic Decompressive Laminotomy</intervention_name>
    <description>2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.</description>
    <arm_group_label>IEDL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Neurogenic claudication or radicular leg pain with or without back pain, and/or a&#xD;
             neurological deficit&#xD;
&#xD;
          2. Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown&#xD;
             on MRI. (Degenerative and congenital bony stenosis were included)&#xD;
&#xD;
          3. Failure of 3 months conservative treatment&#xD;
&#xD;
          4. Grade I degenerative spondylolisthesis and degenerative scoliosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Segmental Instability&#xD;
&#xD;
          2. Lytic Spondylolisthesis&#xD;
&#xD;
        2- Predominant low back pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>hesham magdi soliman</investigator_full_name>
    <investigator_title>Lecturer of Orthopedic Surgery</investigator_title>
  </responsible_party>
  <keyword>IEDL</keyword>
  <keyword>irrigation endoscopic decompressive laminotomy</keyword>
  <keyword>irrigation endoscopic decompression</keyword>
  <keyword>minimally invasive spine surgery</keyword>
  <keyword>endoscopic decompression</keyword>
  <keyword>spinal stenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_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/NCT02254590
org study id: Kasr Einy
nct id: NCT02254590
lead sponsor: 
has dmc: No
To evaluate a new endoscopic technique for lumbar spinal canal decompression.
104 consecutive patients suffering of neurogenic claudication were included in the study.

      Patients were operated using the irrigation endoscopic decompression technique. Mean Follow
      up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index
      [19] and the modified Macnab Criteria All statistical calculations were done using computer
      programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA)
      version 15 for Microsoft Windows
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oswestry Disability Index
time frame: 24 months
description: Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling
measure: Modified Macnab criteria
time frame: 24 months
description: patient satisfaction, the need for medications, ability to return to activity
measure: Time for ambulation
time frame: 72 hours
description: postoperative time required to start ambulation
measure: Time for hospitalization
time frame: 72 hours
description: postoperative hospital stay till discharge
measure: VAS for back pain
time frame: 72 hours
description: Pain intensity on scale from 0-10
arm group label: IEDL
arm group type: Experimental
description: Endoscopic decompression of spinal stenosis
intervention type: Procedure
intervention name: Irrigation Endoscopic Decompressive Laminotomy
description: 2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.
arm group label: IEDL
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: hesham magdi soliman
investigator title: Lecturer of Orthopedic Surgery
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic