Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial

Study Overview
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Brief Summary
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This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis

Official Title
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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

Conditions
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Degenerative Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: BESS
* Procedure: ULBD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BESS, biportal endoscopic spine surgery<br>Biportal endoscopic decompression surgery for lumbar spinal stenosis | Procedure: BESS<br>* Biportal endoscopic surgery<br>|
| Active Comparator: ULBD, unilateral laminotomy bilateral decompression<br>Minimally invasive ULBD for lumbar spinal stenosis | Procedure: ULBD<br>* Unilateral laminotomy bilateral decompression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3, 6, and 12, months, and every year, up to 5 year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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) | up to 1 month after operation | 
| Operation duration | Intraoperative time in minutes | Immediate after operation | 
| Postoperative drainage | Total drainage after surgery in milli-liter | Within 3 days after operation | 
| Amount of transfusion | Total transfusion during and after surgery in milli-liter | Within 7 days after operation | 
| Completeness of decompression | After surgery, degree of decompression was measured using postoperative MRI | Within 3 days after operation | 
| Creatine phosphokinase level in blood | Creatine phosphokinase assessment to measure muscle injury at operation | At 2 day after surgery | 
| Postoperative Fentanyl consumption | Total amount of fentanyl consumption after surgery (PCA dose + rescue dose) | At 3 days after operation | 
| Hospital stay | Total hospital stay after surgery | Within 7 days after operation | 
| Radiographic complications | Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture | 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 | At 1 year after operation |