Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Patient complication rate
研究概览
简要总结
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods.
With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE).
Currently, SE is considered as the minimally invasive surgery gold standard for HDL but, over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques.
As an emerging technique, further studies are needed to better understand UBE. This is why Dr. Cristini's team wish to analyze a cohort of patients for whom this technique has been used since July 2022, in particular the complication rate.
Controlling a new technique requires a learning phase. This is why Dr. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.
详细描述
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica, affecting 1 to 5% of the population each year. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods.
With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Compared to traditional open surgery, minimally invasive surgical technique offers muscle and bone sparing, pain reduction and faster recovery, allowing patient management in Enhanced Recovery After Surgery (RAAC).
Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE). SE relies on a single entry route whereas UBE is based on two entry routes : one way for optical instruments and saline irrigation system and one way for surgical instruments. Currently, SE is considered as the minimally invasive surgery gold standard for HDL treatment thanks to its advantages for controlling muscles trauma, reducing hospital stay and maintaining spinal segment stability.
Over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques.
UBE allows a wider field of vision, wide and ergonomic operating gestures, is minimally invasive and contributes to complete nervous decompression and faster recovery. With UBE, the surgeon can use one hand to guide endoscope and he other one to guide surgical instruments . In addition, UBE generates less trauma, less bleeding, rapid recovery and good effectiveness in HDL treatment . UBE can significantly reduce postoperative nerve fibrosis, and postoperative spinal instability incidence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, over 18 years old
- •Patient with lumbar disc herniation or non-instrumented degenerative lumbar pathology
- •Patient operated with UBE technique
排除标准
- •Patient with extreme lateral disc herniation.
- •Patient suffering from other serious illnesses
- •Patient with lumbar instability, lumbar infection or lumbar tumor,
- •Patient with multi-segmental lumbar disease requiring treatment
结局指标
主要结局
Patient complication rate
时间窗: 2 days
Complications will include epidural hematoma, nerve root injury, neurological deficit, dural breach or tear, incomplete surgery, epileptic crisis, hypothermia. Other complications will be HDL recurrence, pain neuropathy, infection and thromboembolic complications
次要结局
- surgeon learning curve(21 months)