Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Postoperative hospital stay
研究概览
简要总结
The goal of this randomized clinical trial is to investigate whether modified enhanced recovery after surgery (ERAS) in oblique lumbar interbody fusion (OLIF) can shorten the postoperative hospital stay among patients with lumbar degenerative disease.
The main questions it aims to answer are:
Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.
Participants will be randomized into modified ERAS group, or control group.
详细描述
The main questions it aims to answer are:
Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.
Participants will be randomized into modified ERAS group, or control group.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old;
- •Lumbar degenerative diseases that meet the indications of fusion surgery;
- •Patients who are suitable for OLIF surgery;
- •Patients who have actually completed OLIF surgery;
- •The number of fusion segments is less than or equal to two;
- •There was no basis for serious diseases of brain, lung, kidney and other important organs, and preoperative American Society of Anesthesiologists (ASA) score was I-III;
- •Agree to participate in the study and sign the informed consent form.
排除标准
- •Patients undergoing lumbar fusion surgery due to spinal trauma;
- •Patients undergoing lumbar fusion surgery due to spinal tumor resection;
- •Revision surgery;
- •The number of fused segments is more than 2;
- •Simultaneous lumbar fusion via other approaches, such as transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), etc.;
- •Pregnancy or perinatal period;
- •Blood system diseases lead to coagulation dysfunction;
- •Combined with other diseases, life expectancy less than 2 years;
- •Patients is participating in other clinical trials.
结局指标
主要结局
Postoperative hospital stay
时间窗: From the date of surgery to discharge, assessed up to 1 month
The length of hospital stay post-operation.
次要结局
- Postoperative functional recovery(From the date of surgery to discharge, assessed up to 1 month)
- Postoperative pain score(From the date of surgery to 1 year post-operation)
- Postoperative life quality assessment(From the date of surgery to 1 year post-operation)
- Postoperative lumbar neurological function assessment(From the date of surgery to 1 year post-operation)