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出境医 / 临床实验 / Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial (BESS)

Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial (BESS)

Study Description
Brief Summary:
This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine

Condition or disease Intervention/treatment Phase
Lumbar Herniated Intervertebral Disc Procedure: Biportal endoscopy Procedure: Microdiscectomy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Biportal endoscopic discectomy
Biportal endoscopic discectomy for lumbar herniated intervertebral disc
Procedure: Biportal endoscopy
Biportal endoscopic spine surgery (BESS)

Active Comparator: Microdiscectomy
Microdiscectomy for lumbar herniated intervertebral disc
Procedure: Microdiscectomy
Using microscope for discectomy

Outcome Measures
Primary Outcome Measures :
  1. Oswestry disability index (ODI) [ Time Frame: at 1 year after surgery ]

    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



Secondary Outcome Measures :
  1. Change from baseline Oswestry disability index (ODI) [ Time Frame: 3, 6, and 12, months, and every year, up to 5 year after operation ]
    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.

  2. Change from baseline 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 ]
    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.

  3. Change from baseline EuroQoL-5 dimension (EQ-5D) value [ Time Frame: 3, 6, and 12, months, and every year, up to 5 year after operation ]
    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. Rated level can be coded as a number 1 to 5, which indicates having no problems for 1, and having extreme problems for 5. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions). EQ-5D health states may be converted into a single index value. The index values are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions. The value sets are anchored on 11111 = 1 and 55555 = 0 and can therefore be used in QALY calculations.

  4. Change from baseline PainDETECT score [ Time Frame: 3, 6, and 12, months, and every year, up to 5 year after operation ]
    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.

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 1 month after operation ]
    Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)

  6. Operation duration time (minutes) [ Time Frame: Immediate after operation ]
    Intraoperative time in minutes

  7. Volume of postoperative drainage (ml) [ Time Frame: Within 3 days after operation ]
    Total drainage after surgery in milli-liter

  8. Number of participants with complete discectomy [ Time Frame: Within 3 days after operation ]
    After surgery, degree of discectomy was measured using postoperative MRI

  9. Concentration of creatine phosphokinase level in blood [ Time Frame: At 2 day after surgery ]
    Creatine phosphokinase assessment to measure muscle injury at operation

  10. Volume of postoperative Fentanyl consumption [ Time Frame: At 3 days after operation ]
    Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)

  11. Times of hospital stay (hours) [ Time Frame: Within 7 days after operation ]
    Total hospital stay after surgery

  12. Number of radiographic complications [ Time Frame: every year, up to 5 year after operation ]
    Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged between 20 and 80
  • patients who has radiating pain (VAS >=40) on lower extremities with HIVD
  • patients who required one-level discectomy between L1 and S1
  • those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

  • Revision surgery
  • Over spondylolisthesis Gr II
  • Degenerative lumbar scoliosis (Cobb angle >20)
  • patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
  • women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
  • patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
  • patients with mental retardation or whose parents or legal guardians were older or had mental disabilities
  • other patients viewed as inappropriate by the staff
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sang-Min Park, M.D. 82-31-787-7810 psmini@snubh.org

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyounggido, Korea, Republic of
Contact: Sang-Min Park, M.D.       psmini@naver.com   
Sub-Investigator: Jin S. Yeom, M.D.         
Principal Investigator: Sang-Min Park, M.D.         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Ho-Jin Lee, M.D.    82-42-280-7345    leeleo98@gmail.com   
Principal Investigator: Ho-Jin Lee, M.D         
Sponsors and Collaborators
Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
Oswestry disability index (ODI) [ Time Frame: at 1 year after surgery ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Change from baseline Oswestry disability index (ODI) [ Time Frame: 3, 6, and 12, months, and every year, up to 5 year after operation ]
    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.
  • Change from baseline 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 ]
    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.
  • Change from baseline EuroQoL-5 dimension (EQ-5D) value [ Time Frame: 3, 6, and 12, months, and every year, up to 5 year after operation ]
    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. Rated level can be coded as a number 1 to 5, which indicates having no problems for 1, and having extreme problems for 5. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions). EQ-5D health states may be converted into a single index value. The index values are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions. The value sets are anchored on 11111 = 1 and 55555 = 0 and can therefore be used in QALY calculations.
  • Change from baseline PainDETECT score [ Time Frame: 3, 6, and 12, months, and every year, up to 5 year after operation ]
    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.
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 1 month after operation ]
    Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
  • Operation duration time (minutes) [ Time Frame: Immediate after operation ]
    Intraoperative time in minutes
  • Volume of postoperative drainage (ml) [ Time Frame: Within 3 days after operation ]
    Total drainage after surgery in milli-liter
  • Number of participants with complete discectomy [ Time Frame: Within 3 days after operation ]
    After surgery, degree of discectomy was measured using postoperative MRI
  • Concentration of creatine phosphokinase level in blood [ Time Frame: At 2 day after surgery ]
    Creatine phosphokinase assessment to measure muscle injury at operation
  • Volume of postoperative Fentanyl consumption [ Time Frame: At 3 days after operation ]
    Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
  • Times of hospital stay (hours) [ Time Frame: Within 7 days after operation ]
    Total hospital stay after surgery
  • Number of radiographic complications [ Time Frame: every year, up to 5 year after operation ]
    Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial
Official Title  ICMJE Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial
Brief Summary This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Herniated Intervertebral Disc
Intervention  ICMJE
  • Procedure: Biportal endoscopy
    Biportal endoscopic spine surgery (BESS)
  • Procedure: Microdiscectomy
    Using microscope for discectomy
Study Arms  ICMJE
  • Experimental: Biportal endoscopic discectomy
    Biportal endoscopic discectomy for lumbar herniated intervertebral disc
    Intervention: Procedure: Biportal endoscopy
  • Active Comparator: Microdiscectomy
    Microdiscectomy for lumbar herniated intervertebral disc
    Intervention: Procedure: Microdiscectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients aged between 20 and 80
  • patients who has radiating pain (VAS >=40) on lower extremities with HIVD
  • patients who required one-level discectomy between L1 and S1
  • those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

  • Revision surgery
  • Over spondylolisthesis Gr II
  • Degenerative lumbar scoliosis (Cobb angle >20)
  • patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
  • women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
  • patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
  • patients with mental retardation or whose parents or legal guardians were older or had mental disabilities
  • other patients viewed as inappropriate by the staff
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sang-Min Park, M.D. 82-31-787-7810 psmini@snubh.org
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924700
Other Study ID Numbers  ICMJE BESS_002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin S. Yeom, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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