<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/NCT04465305</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUTHNSD</org_study_id>
    <nct_id>NCT04465305</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement</brief_title>
  <acronym>ARCSTSCC</acronym>
  <official_title>A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Science &amp; Technology Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 subject will treat 68 patients with symptomatic sacral canal cysts as the research&#xD;
      object, and adopt a randomized controlled research method, respectively, using two methods of&#xD;
      reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve&#xD;
      plasty, and observed the operation of the patient Complications, preoperative and&#xD;
      postoperative short-term and long-term VAS pain scores, JOA neural function scores, and&#xD;
      changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve&#xD;
      reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex&#xD;
      and effectiveness, so as to further improve the surgical treatment of sacral canal cysts,&#xD;
      improve the curative effect, and formulate the operation specifications for the treatment of&#xD;
      sacral canal cyst&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this subject, a cohort observation method was used to observe 52 patients with two types&#xD;
      of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound&#xD;
      through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of&#xD;
      frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the&#xD;
      endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the&#xD;
      guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases&#xD;
      in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery.&#xD;
      Observe the removal rate of surgical hematoma in the two groups And the safety of the&#xD;
      operation and the GCS score, GOS score and MRI examination of nerve fiber damage and&#xD;
      postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and&#xD;
      analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And&#xD;
      whether it has an advantage in terms of efficacy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recurrent rate of tarlov cysts</measure>
    <time_frame>1 year</time_frame>
    <description>patents who recurrent postoperation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Tarlov Cysts</condition>
  <arm_group>
    <arm_group_label>enraped group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with a new treatment of tarlov cysts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>plasty group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with traditional treatment of tarlov cysts</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>entraped treatment</intervention_name>
    <description>patients with tarlov cysts treated by entraped and plasty nerve root</description>
    <arm_group_label>enraped group</arm_group_label>
    <other_name>plasty treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>plasty treatment</intervention_name>
    <description>patients with tarlov cysts treated by plasty nerve root</description>
    <arm_group_label>enraped group</arm_group_label>
    <arm_group_label>plasty group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptomatic nerve root cysts diagnosed by MRI&#xD;
&#xD;
          2. Intact cyst capsule, no defect of sacral canal lamina&#xD;
&#xD;
          3. No other diseases of nervous system, pelvic floor and important organs&#xD;
&#xD;
          4. Agree inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina&#xD;
        resorption c) Combined with other diseases of nervous system, pelvic floor and important&#xD;
        organs d) Disagree to join e) Cannot complete follow-up -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>liu bin</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>wang zhenyu</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>xie jinchen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>liu bin</last_name>
    <phone>13671027688</phone>
    <email>liubin301@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>wu chao</last_name>
    <phone>82267358</phone>
    <phone_ext>086010</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Peking</city>
        <state>Haidian</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>liu bin</last_name>
      <phone>13671027688</phone>
      <email>liubin301@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 4, 2021</last_update_submitted>
  <last_update_submitted_qc>July 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tarlov cysts surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Tarlov Cysts</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04465305
org study id: PekingUTHNSD
nct id: NCT04465305
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The subject will treat 68 patients with symptomatic sacral canal cysts as the research
      object, and adopt a randomized controlled research method, respectively, using two methods of
      reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve
      plasty, and observed the operation of the patient Complications, preoperative and
      postoperative short-term and long-term VAS pain scores, JOA neural function scores, and
      changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve
      reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex
      and effectiveness, so as to further improve the surgical treatment of sacral canal cysts,
      improve the curative effect, and formulate the operation specifications for the treatment of
      sacral canal cyst
In this subject, a cohort observation method was used to observe 52 patients with two types
      of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound
      through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of
      frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the
      endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the
      guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases
      in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery.
      Observe the removal rate of surgical hematoma in the two groups And the safety of the
      operation and the GCS score, GOS score and MRI examination of nerve fiber damage and
      postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and
      analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And
      whether it has an advantage in terms of efficacy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: recurrent rate of tarlov cysts
time frame: 1 year
description: patents who recurrent postoperation
arm group label: enraped group
arm group type: Experimental
description: patients with a new treatment of tarlov cysts
arm group label: plasty group
arm group type: Active Comparator
description: patients with traditional treatment of tarlov cysts
intervention type: Procedure
intervention name: entraped treatment
description: patients with tarlov cysts treated by entraped and plasty nerve root
arm group label: enraped group
other name: plasty treatment
intervention type: Procedure
intervention name: plasty treatment
description: patients with tarlov cysts treated by plasty nerve root
arm group label: enraped group
arm group label: plasty group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: liu bin
role: Study Chair
affiliation: Peking University Third Hospital
last name: wang zhenyu
role: Study Director
affiliation: Peking University Third Hospital
last name: xie jinchen
role: Principal Investigator
affiliation: Peking University Third Hospital
last name: liu bin
phone: 13671027688
email: liubin301@163.com
last name: wu chao
phone: 82267358
phone ext: 086010
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Cysts
mesh term: Tarlov Cysts
sharing ipd: No