Lumbar Herniated Intervertebral Disc
Conditions
Keywords
Herniated intervertebral disc, Discectomy, Microscope, Biportal endoscopy
Brief summary
This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine
Interventions
PROCEDUREBiportal endoscopy
Biportal endoscopic spine surgery (BESS)
PROCEDUREMicrodiscectomy
Using microscope for discectomy
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry disability index (ODI) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Oswestry disability index (ODI) | 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. |
| Change from baseline Visual Analog Pain Scale (VAS) | 4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation | 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. |
| Change from baseline EuroQoL-5 dimension (EQ-5D) value | 3, 6, and 12, months, and every year, up to 5 year after operation | 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. |
| Change from baseline PainDETECT score | 3, 6, and 12, months, and every year, up to 5 year after operation | 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. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 1 month after operation | Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission) |
| Number of radiographic complications | every year, up to 5 year after operation | Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture... |
| Volume of postoperative drainage (ml) | Within 3 days after operation | Total drainage after surgery in milli-liter |
| Number of participants with complete discectomy | Within 3 days after operation | After surgery, degree of discectomy was measured using postoperative MRI |
| Concentration of creatine phosphokinase level in blood | At 2 day after surgery | Creatine phosphokinase assessment to measure muscle injury at operation |
| Volume of postoperative Fentanyl consumption | At 3 days after operation | Total amount of fentanyl consumption after surgery (PCA dose + rescue dose) |
| Times of hospital stay (hours) | Within 7 days after operation | Total hospital stay after surgery |
| Operation duration time (minutes) | Immediate after operation | Intraoperative time in minutes |
Countries
South Korea
Outcome results
None listed