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This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biportal endoscopic discectomy | Experimental | Biportal endoscopic discectomy for lumbar herniated intervertebral disc |
|
| Microdiscectomy | Active Comparator | Microdiscectomy for lumbar herniated intervertebral disc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biportal endoscopy | Procedure | Biportal endoscopic spine surgery (BESS) |
| |
| 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 | at 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | |||
| Chungnam National University Hospital |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Microdiscectomy |
| Procedure |
Using microscope for discectomy |
|
| 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. | 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. | 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. | 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 time (minutes) | Intraoperative time in minutes | Immediate after operation |
| Volume of postoperative drainage (ml) | Total drainage after surgery in milli-liter | Within 3 days after operation |
| Number of participants with complete discectomy | After surgery, degree of discectomy was measured using postoperative MRI | Within 3 days after operation |
| Concentration of creatine phosphokinase level in blood | Creatine phosphokinase assessment to measure muscle injury at operation | At 2 day after surgery |
| Volume of postoperative Fentanyl consumption | Total amount of fentanyl consumption after surgery (PCA dose + rescue dose) | At 3 days after operation |
| Times of hospital stay (hours) | Total hospital stay after surgery | 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... | every year, up to 5 year after operation |
| Daejeon |
| 35015 |
| South Korea |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |