<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/NCT03302507</url>
  </required_header>
  <id_info>
    <org_study_id>BESS_001</org_study_id>
    <nct_id>NCT03302507</nct_id>
  </id_info>
  <brief_title>Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial</brief_title>
  <official_title>Outcomes Following Bilateral Decompression Surgery in Lumbar Spinal Stenosis With Biportal Endoscopy Versus Unilateral Laminotomy Technique: A Prospective, Single-blinded, Randomized Controlled Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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>
      This study is to compare the clinical outcome between the biportal endoscopic decompression&#xD;
      and the unilateral approach bilateral decompression in spinal stenosis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry disability index (ODI)</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.&#xD;
This is assessed by ODI survey at 1 year after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Pain Scale (VAS)</measure>
    <time_frame>4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PainDETECT</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>up to 1 month after operation</time_frame>
    <description>Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation duration</measure>
    <time_frame>Immediate after operation</time_frame>
    <description>Intraoperative time in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative drainage</measure>
    <time_frame>Within 3 days after operation</time_frame>
    <description>Total drainage after surgery in milli-liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of transfusion</measure>
    <time_frame>Within 7 days after operation</time_frame>
    <description>Total transfusion during and after surgery in milli-liter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completeness of decompression</measure>
    <time_frame>Within 3 days after operation</time_frame>
    <description>After surgery, degree of decompression was measured using postoperative MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatine phosphokinase level in blood</measure>
    <time_frame>At 2 day after surgery</time_frame>
    <description>Creatine phosphokinase assessment to measure muscle injury at operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Fentanyl consumption</measure>
    <time_frame>At 3 days after operation</time_frame>
    <description>Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Within 7 days after operation</time_frame>
    <description>Total hospital stay after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic complications</measure>
    <time_frame>every year, up to 5 year after operation,</time_frame>
    <description>Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction scale</measure>
    <time_frame>At 1 year after operation</time_frame>
    <description>Satisfaction scale is a short self-report questionnaire for evaluating patient satisfaction with the outcome of lumbar decompression surgery. Items are scored on a 7-point Likert scale with response categories consisting from very satisfied (7 points) to very dissatisfied (1 points).&#xD;
Satisfaction after operation at 1 year after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Degenerative Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>BESS, biportal endoscopic spine surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biportal endoscopic decompression surgery for lumbar spinal stenosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ULBD, unilateral laminotomy bilateral decompression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimally invasive ULBD for lumbar spinal stenosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BESS</intervention_name>
    <description>Biportal endoscopic surgery</description>
    <arm_group_label>BESS, biportal endoscopic spine surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ULBD</intervention_name>
    <description>Unilateral laminotomy bilateral decompression</description>
    <arm_group_label>ULBD, unilateral laminotomy bilateral decompression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged between 30 and 80&#xD;
&#xD;
          -  patients who has radiating pain (VAS &gt;=40) on lower extremities with spinal stenosis&#xD;
             over Gr B&#xD;
&#xD;
          -  patients who required one-level decompression between L1 and S1&#xD;
&#xD;
          -  those who (only if a signature was obtainable), or whose legal guardian, fully&#xD;
             understood the clinical trial details and signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision surgery&#xD;
&#xD;
          -  Over spondylolisthesis Gr II&#xD;
&#xD;
          -  Degenerative lumbar scoliosis (Cobb angle &gt;20)&#xD;
&#xD;
          -  herniated disc&#xD;
&#xD;
          -  patients with a history of other spinal diseases (compression fracture, spondylitis,&#xD;
             tumor)&#xD;
&#xD;
          -  women with positive pregnancy tests before the trial or who planned to become pregnant&#xD;
             within the following 3 years&#xD;
&#xD;
          -  patients with a history of malignant tumor or malignant diseases (but the cases of&#xD;
             cured disease with no relapse for the past 5 years were included in the present study)&#xD;
&#xD;
          -  patients with mental retardation or whose parents or legal guardians were older or had&#xD;
             mental disabilities&#xD;
&#xD;
          -  other patients viewed as inappropriate by the staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyounggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 10, 2019</last_update_submitted>
  <last_update_submitted_qc>October 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin S. Yeom</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03302507
org study id: BESS_001
nct id: NCT03302507
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to compare the clinical outcome between the biportal endoscopic decompression
      and the unilateral approach bilateral decompression in spinal stenosis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Oswestry disability index (ODI)
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.
This is assessed by ODI survey at 1 year after surgery
measure: Visual Analog Pain Scale (VAS)
time frame: 4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation
description: VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.
measure: EQ-5D
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
measure: PainDETECT
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: up to 1 month after operation
description: Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
measure: Operation duration
time frame: Immediate after operation
description: Intraoperative time in minutes
measure: Postoperative drainage
time frame: Within 3 days after operation
description: Total drainage after surgery in milli-liter
measure: Amount of transfusion
time frame: Within 7 days after operation
description: Total transfusion during and after surgery in milli-liter
measure: Completeness of decompression
time frame: Within 3 days after operation
description: After surgery, degree of decompression was measured using postoperative MRI
measure: Creatine phosphokinase level in blood
time frame: At 2 day after surgery
description: Creatine phosphokinase assessment to measure muscle injury at operation
measure: Postoperative Fentanyl consumption
time frame: At 3 days after operation
description: Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
measure: Hospital stay
time frame: Within 7 days after operation
description: Total hospital stay after surgery
measure: Radiographic complications
time frame: every year, up to 5 year after operation,
description: Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture
measure: Satisfaction scale
time frame: At 1 year after operation
description: Satisfaction scale is a short self-report questionnaire for evaluating patient satisfaction with the outcome of lumbar decompression surgery. Items are scored on a 7-point Likert scale with response categories consisting from very satisfied (7 points) to very dissatisfied (1 points).
Satisfaction after operation at 1 year after surgery
arm group label: BESS, biportal endoscopic spine surgery
arm group type: Experimental
description: Biportal endoscopic decompression surgery for lumbar spinal stenosis
arm group label: ULBD, unilateral laminotomy bilateral decompression
arm group type: Active Comparator
description: Minimally invasive ULBD for lumbar spinal stenosis
intervention type: Procedure
intervention name: BESS
description: Biportal endoscopic surgery
arm group label: BESS, biportal endoscopic spine surgery
intervention type: Procedure
intervention name: ULBD
description: Unilateral laminotomy bilateral decompression
arm group label: ULBD, unilateral laminotomy bilateral decompression
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin S. Yeom
investigator title: Professor
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic