Lumbar Herniated Intervertebral DiscBESSNCT03924700
Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial
A study testing Biportal endoscopy and Microdiscectomy in people with Lumbar Herniated Intervertebral Disc, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lumbar Herniated Intervertebral Disc
- What is being tested?
- Biportal endoscopy and Microdiscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 28 Apr 2019to 28 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chungnam National University Hospital
Daejeon, 35015
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido
About this study
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
This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine
- Conditions
- Lumbar Herniated Intervertebral Disc
- Being tested
- Biportal endoscopy, Microdiscectomy
- Keywords
- Herniated intervertebral disc, Discectomy, Microscope, Biportal endoscopy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biportal endoscopyProcedure or surgery
Biportal endoscopic spine surgery (BESS)
MicrodiscectomyProcedure or surgery
Using microscope for discectomy
| Study group | Role | What they receive |
|---|---|---|
| Biportal endoscopic discectomy | Experimental | Biportal endoscopic discectomy for lumbar herniated intervertebral disc Receives: Procedure: Biportal endoscopy |
| Microdiscectomy | Active comparator | Microdiscectomy for lumbar herniated intervertebral disc Receives: Procedure: Microdiscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 1 year after surgery
Secondary outcomes (12)
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.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
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.
Measured: 4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation
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.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
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.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
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)
Measured: up to 1 month after operation
Operation duration time (minutes)
Intraoperative time in minutes
Measured: Immediate after operation
Volume of postoperative drainage (ml)
Total drainage after surgery in milli-liter
Measured: Within 3 days after operation
Number of participants with complete discectomy
After surgery, degree of discectomy was measured using postoperative MRI
Measured: Within 3 days after operation
Concentration of creatine phosphokinase level in blood
Creatine phosphokinase assessment to measure muscle injury at operation
Measured: At 2 day after surgery
Volume of postoperative Fentanyl consumption
Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
Measured: At 3 days after operation
Times of hospital stay (hours)
Total hospital stay after surgery
Measured: Within 7 days after operation
Number of radiographic complications
Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...
Measured: every year, up to 5 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start28 Apr 2019
- Primary completion30 Nov 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Herniated Intervertebral DiscStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924700
- Sponsor's protocol ID
- BESS_002
- Acronym
- BESS
- Status last verified
- Mar 2022
- First submitted
- 17 Apr 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03924700
- Acronym / sponsor ID
- BESS / BESS_002
- Conditions
- Lumbar Herniated Intervertebral Disc
- Keywords
- Herniated intervertebral disc, Discectomy, Microscope, Biportal endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biportal endoscopic discectomy | Experimental | Procedure: Biportal endoscopyBiportal endoscopic discectomy for lumbar herniated intervertebral disc |
| Microdiscectomy | Active comparator | Procedure: MicrodiscectomyMicrodiscectomy for lumbar herniated intervertebral disc |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biportal endoscopyBiportal endoscopic spine surgery (BESS) | Procedure or surgery | Biportal endoscopic discectomy |
| MicrodiscectomyUsing microscope for discectomy | Procedure or surgery | Microdiscectomy |
Primary outcome
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
12 secondary outcomes
Change from baseline Oswestry disability index (ODI)
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
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
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
Change from baseline PainDETECT score
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 1 month after operation
Operation duration time (minutes)
Time frame: Immediate after operation
Volume of postoperative drainage (ml)
Time frame: Within 3 days after operation
Number of participants with complete discectomy
Time frame: Within 3 days after operation
Concentration of creatine phosphokinase level in blood
Time frame: At 2 day after surgery
Volume of postoperative Fentanyl consumption
Time frame: At 3 days after operation
Times of hospital stay (hours)
Time frame: Within 7 days after operation
Number of radiographic complications
Time frame: every year, up to 5 year after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
Related trials for Lumbar Herniated Intervertebral Disc
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biportal endoscopy and Microdiscectomy in people with Lumbar Herniated Intervertebral Disc, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability index (ODI) (time frame: at 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.