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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BESS, biportal endoscopic spine surgery | Experimental | Biportal endoscopic decompression surgery for lumbar spinal stenosis |
|
| ULBD, unilateral laminotomy bilateral decompression | Active Comparator | Minimally invasive ULBD for lumbar spinal stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BESS | Procedure | Biportal endoscopic surgery |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyounggido | South Korea |
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| ULBD |
| Procedure |
Unilateral laminotomy bilateral decompression |
|
| 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 |