Biportal Endoscopic Discectomy Versus Microdiscectomy: 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 discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine

Official Title
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Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial

Conditions
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Lumbar Herniated Intervertebral Disc

Intervention / Treatment
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* Procedure: Biportal endoscopy
* Procedure: Microdiscectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 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: Biportal endoscopic discectomy<br>Biportal endoscopic discectomy for lumbar herniated intervertebral disc | Procedure: Biportal endoscopy<br>* Biportal endoscopic spine surgery (BESS)<br>|
| Active Comparator: Microdiscectomy<br>Microdiscectomy for lumbar herniated intervertebral disc | Procedure: Microdiscectomy<br>* Using microscope for discectomy<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 | at 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herniated intervertebral disc, Discectomy, Microscope, Biportal endoscopy