NCT03302507已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Oswestry disability index (ODI)
研究概览
简要总结
This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BESS, biportal endoscopic spine surgery
Experimental
Biportal endoscopic decompression surgery for lumbar spinal stenosis
干预措施: BESS (Procedure)
ULBD, unilateral laminotomy bilateral decompression
Active Comparator
Minimally invasive ULBD for lumbar spinal stenosis
干预措施: ULBD (Procedure)
结局指标
主要结局
Oswestry disability index (ODI)
时间窗: 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. This is assessed by ODI survey at 1 year after surgery
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 1 month after operation)
- Operation duration(Immediate after operation)
- Postoperative drainage(Within 3 days after operation)
- 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)
- EQ-5D(3, 6, and 12, months, and every year, up to 5 year after operation)
- PainDETECT(3, 6, and 12, months, and every year, up to 5 year after operation)
- Completeness of decompression(Within 3 days after operation)
- Creatine phosphokinase level in blood(At 2 day after surgery)
- Postoperative Fentanyl consumption(At 3 days after operation)
- Satisfaction scale(At 1 year after operation)
- Amount of transfusion(Within 7 days after operation)
- Hospital stay(Within 7 days after operation)
- Radiographic complications(every year, up to 5 year after operation,)
研究者
Jin S. Yeom
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison clinical outcomes between Ipsilateral and Alternate-lateral Biportal endoscopic decompression for lumbar spinal stenosisPatient who had diagnosed by clinical examination and magnetic resonance imaging identified that lumbar spinal stenosis two to three adjacent levelSpinal stenosisTCTR20240625001Research Faculty of Medicine40
尚未招募
不适用
Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal StenosisLumbar Spinal StenosisNCT06381167Assiut University52
尚未招募
不适用
Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar SpondylolisthesisDegenerative Lumbar SpondylolisthesisLumbar Spinal StenosisLumbar Degenerative DiseaseNCT06749314Queen Savang Vadhana Memorial Hospital, Thailand66
已完成
不适用
Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority TrialLumbar Herniated Intervertebral DiscNCT03924700Seoul National University Hospital64
尚未招募
不适用
Two Portal Percutaneous Endoscopic Decompression vs Open Decompression for Lumbar Spinal Stenosis: Prospective Randomizer Control Trial-intra-operative complications-improve post-operative outcomepercutaneous endoscopicdecompressionlumbarTCTR20150622001no60