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

Primary Purpose

Lumbar Herniated Intervertebral Disc

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biportal endoscopy
Microdiscectomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Herniated Intervertebral Disc focused on measuring Herniated intervertebral disc, Discectomy, Microscope, Biportal endoscopy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Chungnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biportal endoscopic discectomy

Microdiscectomy

Arm Description

Biportal endoscopic discectomy for lumbar herniated intervertebral disc

Microdiscectomy for lumbar herniated intervertebral disc

Outcomes

Primary Outcome Measures

Oswestry disability index (ODI)
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

Change from baseline Oswestry disability index (ODI)
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)
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
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
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
Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
Operation duration time (minutes)
Intraoperative time in minutes
Volume of postoperative drainage (ml)
Total drainage after surgery in milli-liter
Number of participants with complete discectomy
After surgery, degree of discectomy was measured using postoperative MRI
Concentration of creatine phosphokinase level in blood
Creatine phosphokinase assessment to measure muscle injury at operation
Volume of postoperative Fentanyl consumption
Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
Times of hospital stay (hours)
Total hospital stay after surgery
Number of radiographic complications
Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...

Full Information

First Posted
April 17, 2019
Last Updated
March 21, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03924700
Brief Title
Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial
Acronym
BESS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 28, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Herniated Intervertebral Disc
Keywords
Herniated intervertebral disc, Discectomy, Microscope, Biportal endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biportal endoscopic discectomy
Arm Type
Experimental
Arm Description
Biportal endoscopic discectomy for lumbar herniated intervertebral disc
Arm Title
Microdiscectomy
Arm Type
Active Comparator
Arm Description
Microdiscectomy for lumbar herniated intervertebral disc
Intervention Type
Procedure
Intervention Name(s)
Biportal endoscopy
Intervention Description
Biportal endoscopic spine surgery (BESS)
Intervention Type
Procedure
Intervention Name(s)
Microdiscectomy
Intervention Description
Using microscope for discectomy
Primary Outcome Measure Information:
Title
Oswestry disability index (ODI)
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
Time Frame
at 1 year after surgery
Secondary Outcome Measure Information:
Title
Change from baseline Oswestry disability index (ODI)
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.
Time Frame
3, 6, and 12, months, and every year, up to 5 year after operation
Title
Change from baseline Visual Analog Pain Scale (VAS)
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.
Time Frame
4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation
Title
Change from baseline EuroQoL-5 dimension (EQ-5D) value
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. 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.
Time Frame
3, 6, and 12, months, and every year, up to 5 year after operation
Title
Change from baseline PainDETECT score
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.
Time Frame
3, 6, and 12, months, and every year, up to 5 year after operation
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
Time Frame
up to 1 month after operation
Title
Operation duration time (minutes)
Description
Intraoperative time in minutes
Time Frame
Immediate after operation
Title
Volume of postoperative drainage (ml)
Description
Total drainage after surgery in milli-liter
Time Frame
Within 3 days after operation
Title
Number of participants with complete discectomy
Description
After surgery, degree of discectomy was measured using postoperative MRI
Time Frame
Within 3 days after operation
Title
Concentration of creatine phosphokinase level in blood
Description
Creatine phosphokinase assessment to measure muscle injury at operation
Time Frame
At 2 day after surgery
Title
Volume of postoperative Fentanyl consumption
Description
Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
Time Frame
At 3 days after operation
Title
Times of hospital stay (hours)
Description
Total hospital stay after surgery
Time Frame
Within 7 days after operation
Title
Number of radiographic complications
Description
Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...
Time Frame
every year, up to 5 year after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyounggido
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of

12. IPD Sharing Statement

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

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