Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index improvement
研究概览
简要总结
Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme.
The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).
详细描述
On a population of patients undergoing minimally invasive lumbar spine surgery divided into two cohorts of equal size according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme:
Primary objective To compare the percentage of therapeutic success achieved in each group one month after surgery.
Secondary objectives: to compare between groups:
- Postoperative pain intensity at D1 and M1
- Analgesic consumption (in stages) at D1 and M1
- Pain-free walking distance at M1
- Surgery conditions (duration of operation, duration of hospitalisation)
- Frequency of adverse events related to surgery (infection rate, 1 month recovery rate, transfusion requirements)
- Emotional impact of the management
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult male or female (18 years or older)
- •Patient who has agreed to participate in the study and has read and signed the consent form for participation in the study
- •Patient for whom a minimally invasive spine surgery is planned: (dicectomy, lumbar canal recalibration with or without laminectomy, lumbar arthrodesis by posterior approach limited to one stage)
排除标准
- •Patient with a contraindication to spinal anaesthesia
- •A bedridden or institutionalised patient
- •Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- •Patient not affiliated to the French social security system
- •Patient under legal protection, guardianship or curatorship
- •Patient already included in another therapeutic study protocol
结局指标
主要结局
Oswestry Disability Index improvement
时间窗: Month 1
The Oswestry Disability Index (Appendix 1) (also known as the Oswestry Low Back Pain Disability) is the gold standard tool for assessing functional disability related to low back pain and functional recovery after surgery. It consists of ten questions rated from 0 to 5 (from most to least favourable). The result is expressed as a percentage according to the following formula \[score obtained / (maximum score)\] X 100. The maximum score is 50 if all the questions have been filled in, 45 if one question has not been filled in etc..... The disability rate, corresponding to the percentage, obtained is considered minimal between 0 and 20%, moderate between 21 and 40% and severe above 41%. Therapeutic success defined as an improvement ≥30% in the Oswestry Disability Index between initial and final visit is the primary endpoint
次要结局
- Consumption of level I, II and II analgesics(Month 1)
- Length of hospital stay(Month 1)
- Duration of intervention(Day 1)
- Adverse events related to surgery(Month 1)
- Post-operative pain(Month 1)
- Pain-free walking perimeter(Month 1)
- Evolution of Hospital Anxiety and Depression (HAD) scale score and sub-scores(Month 1)
- Visual Analogue Scale overall patient satisfaction(Month 1)