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/NCT06009640</url>
    </required_header>
    <id_info>
      <org_study_id>2022/514/220/8</org_study_id>
      <nct_id>NCT06009640</nct_id>
    </id_info>
    <brief_title>Integration of Intraoperative Neuromonitoring Into Decompression Surgery</brief_title>
    <official_title>Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Lutfi Kirdar Kartal Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr. Lutfi Kirdar Kartal Training and Research Hospital</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>
        To describe a novel technique by integrating the intraoperative neurophysiological monitoring&#xD;
        (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at&#xD;
        risk during surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus&#xD;
        nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4&#xD;
        during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular&#xD;
        conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep&#xD;
        areas of the pelvis. Sacral and sciatic nerves might be damaged when performing decompression&#xD;
        surgery in these deep pelvic areas. We described a novel technique by integrating the&#xD;
        intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves&#xD;
        by continuously monitoring when they are at risk during surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">March 1, 2022</completion_date>
    <primary_completion_date type="Actual">February 1, 2022</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>Pain score assessment with visual Analogic Scale (VAS)</measure>
      <time_frame>1 month</time_frame>
      <description>Pain symptoms (Dysmenorrhea, dyspareunia, dyschezia, sciatic pain, chronic pelvic pain) were evaluated preoperatively , and re-evaluated at the postoperative first month.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Nerve Entrapments</condition>
    <condition>Pelvic Pain</condition>
    <arm_group>
      <arm_group_label>Intraoperative neurophysiological monitoring for decompression surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>we integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4 during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep areas of the pelvis. These areas can be accesed more easily with by laparoscopy, which provides better magnification and visualization. Sacral and sciatic nerves might be damaged when performing decompression surgery in these deep pelvic areas. Patients who gave informed consent and underwent surgical treatment for a proven diagnosis of lumbosacral plexus nerve entrapment were included in the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine</intervention_name>
      <description>Integration of intraoperative neurophysiological monitoring (IONM) into laparoscopic decompression surgery to protect pelvic nerves by continuously monitoring when they are at risk during surgery.</description>
      <arm_group_label>Intraoperative neurophysiological monitoring for decompression surgery</arm_group_label>
      <other_name>Nicolet Endeavor IOM Machine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with symptoms of chronic pelvic pain , dyspareunia, dysmenorrhea and severe,&#xD;
               burning sharp pain on the lower extremity dermatomes, which had been present for at&#xD;
               least one year were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who underwent laparoscopic decompression surgery but did not give informed&#xD;
               consent were not included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elif Gundogdu, M.D.Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kartal Dr. Lutfi Kirdar City Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kartal Dr. Lutfi Kirdar City Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Kartal</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dr. Lutfi Kirdar Kartal Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Elif Cansu Gundogdu</investigator_full_name>
      <investigator_title>Specialist doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nerve Compression Syndromes</mesh_term>
      <mesh_term>Pelvic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06009640
  org study id: 2022/514/220/8
  nct id: NCT06009640
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To describe a novel technique by integrating the intraoperative neurophysiological monitoring
        (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at
        risk during surgery.
  We integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus
        nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4
        during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular
        conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep
        areas of the pelvis. Sacral and sciatic nerves might be damaged when performing decompression
        surgery in these deep pelvic areas. We described a novel technique by integrating the
        intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves
        by continuously monitoring when they are at risk during surgery.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain score assessment with visual Analogic Scale (VAS)
  time frame: 1 month
  description: Pain symptoms (Dysmenorrhea, dyspareunia, dyschezia, sciatic pain, chronic pelvic pain) were evaluated preoperatively , and re-evaluated at the postoperative first month.
  arm group label: Intraoperative neurophysiological monitoring for decompression surgery
  arm group type: Experimental
  description: we integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4 during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep areas of the pelvis. These areas can be accesed more easily with by laparoscopy, which provides better magnification and visualization. Sacral and sciatic nerves might be damaged when performing decompression surgery in these deep pelvic areas. Patients who gave informed consent and underwent surgical treatment for a proven diagnosis of lumbosacral plexus nerve entrapment were included in the study.
  intervention type: Device
  intervention name: Intraoperative neurophysiological monitoring with Nicolet Endeavor IOM Machine
  description: Integration of intraoperative neurophysiological monitoring (IONM) into laparoscopic decompression surgery to protect pelvic nerves by continuously monitoring when they are at risk during surgery.
  arm group label: Intraoperative neurophysiological monitoring for decompression surgery
  other name: Nicolet Endeavor IOM Machine
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elif Gundogdu, M.D.Dr
  role: Principal Investigator
  affiliation: Kartal Dr. Lutfi Kirdar City Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital
  investigator full name: Elif Cansu Gundogdu
  investigator title: Specialist doctor
  mesh term: Nerve Compression Syndromes
  mesh term: Pelvic Pain
  sharing ipd: No