Degenerative Lumbar Spinal StenosisNCT03302507
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
A study testing BESS and ULBD in people with Degenerative Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- BESS and ULBD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2017to 1 Oct 2019
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 30 and 80
- patients who has radiating pain (VAS >=40) on lower extremities with spinal stenosis over Gr B
- patients who required one-level decompression 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)
- herniated disc
- 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
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- 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
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido
About this study
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
This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- BESS, ULBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BESSProcedure or surgery
Biportal endoscopic surgery
ULBDProcedure or surgery
Unilateral laminotomy bilateral decompression
| Study group | Role | What they receive |
|---|---|---|
| BESS, biportal endoscopic spine surgery | Experimental | Biportal endoscopic decompression surgery for lumbar spinal stenosis Receives: Procedure: BESS |
| ULBD, unilateral laminotomy bilateral decompression | Active comparator | Minimally invasive ULBD for lumbar spinal stenosis Receives: Procedure: ULBD |
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: 3, 6, and 12, months, and every year, up to 5 year after operation
Secondary outcomes (13)
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
EQ-5D
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.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
PainDETECT
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
Intraoperative time in minutes
Measured: Immediate after operation
Postoperative drainage
Total drainage after surgery in milli-liter
Measured: Within 3 days after operation
Amount of transfusion
Total transfusion during and after surgery in milli-liter
Measured: Within 7 days after operation
Completeness of decompression
After surgery, degree of decompression was measured using postoperative MRI
Measured: Within 3 days after operation
Creatine phosphokinase level in blood
Creatine phosphokinase assessment to measure muscle injury at operation
Measured: At 2 day after surgery
Postoperative Fentanyl consumption
Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
Measured: At 3 days after operation
Hospital stay
Total hospital stay after surgery
Measured: Within 7 days after operation
Radiographic complications
Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture
Measured: every year, up to 5 year after operation,
Satisfaction scale
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
Measured: At 1 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 posted5 Oct 2017
- Study start1 Nov 2017
- Primary completion30 Jun 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies 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
- Participant
- 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
- NCT03302507
- Sponsor's protocol ID
- BESS_001
- Status last verified
- Oct 2019
- First submitted
- 21 Sep 2017
- Last updated
- 14 Oct 2019
- 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 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03302507
- Acronym / sponsor ID
- BESS_001
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 5 Oct 2017 (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 decompression and the unilateral approach bilateral decompression in spinal stenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BESS, biportal endoscopic spine surgery | Experimental | Procedure: BESSBiportal endoscopic decompression surgery for lumbar spinal stenosis |
| ULBD, unilateral laminotomy bilateral decompression | Active comparator | Procedure: ULBDMinimally invasive ULBD for lumbar spinal stenosis |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged between 30 and 80
- patients who has radiating pain (VAS >=40) on lower extremities with spinal stenosis over Gr B
- patients who required one-level decompression 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 (9 listed)
- Revision surgery
- Over spondylolisthesis Gr II
- Degenerative lumbar scoliosis (Cobb angle >20)
- herniated disc
- patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
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 |
|---|---|---|
| BESSBiportal endoscopic surgery | Procedure or surgery | BESS, biportal endoscopic spine surgery |
| ULBDUnilateral laminotomy bilateral decompression | Procedure or surgery | ULBD, unilateral laminotomy bilateral decompression |
Primary outcome
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. This is assessed by ODI survey at 1 year after surgery
13 secondary outcomes
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
EQ-5D
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
PainDETECT
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 frame: Immediate after operation
Postoperative drainage
Time frame: Within 3 days after operation
Amount of transfusion
Time frame: Within 7 days after operation
Completeness of decompression
Time frame: Within 3 days after operation
Creatine phosphokinase level in blood
Time frame: At 2 day after surgery
Postoperative Fentanyl consumption
Time frame: At 3 days after operation
Hospital stay
Time frame: Within 7 days after operation
Radiographic complications
Time frame: every year, up to 5 year after operation,
Satisfaction scale
Time frame: At 1 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 14 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BESS and ULBD in people with Degenerative Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site 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 9 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: 3, 6, and 12, months, and every year, up to 5 year after operation). 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 14 Oct 2019.