Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- ODI or NDI
研究概览
简要总结
Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome.
详细描述
Rationale: Optimizing outcomes of instrumented neck and back surgery Objective: To demonstrate that smoking cessation in the postoperative period has a positive impact on the clinical and radiological outcomes of instrumented spine surgery Study design: This is a multicenter observational cohort study with three groups of patients indicated to undergo moderately complex instrumented spinal surgery: a group of patients who continue to smoke is compared with a group who stop smoking in the peri-operative period of time. In addition, the results of a group of patients who do not smoke are recorded. Follow-up moments are baseline, 2, 6 and 12 months after surgery.
Study population: Patients between 18 and 75 years of age, who are candidates for moderately complex instrumented surgery of the neck or low back. Patients undergoing surgery for malignancy or trauma are excluded.
Intervention: If patients indicate that they are open to quitting smoking, they will be offered the SineFuma program. After 4 weeks, testing of nicotine in the urine will check whether smoking has actually stopped.
Study parameters: Primary outcome measure is the Oswestry Disability Index (low back) or the Neck Disability Index (neck). Furthermore, the VAS leg pain (or arm pain) and VAS back pain (or neck pain), the Hospital Anxiety and Depression Scale, the EuroQol and the patient's perceived recovery will be evaluated. The bony fusion will be assessed radiologically by CT at 6 and 12 months.
This is a multicenter observational cohort study adjusted for age and ASA score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •candidates for moderately complex instrumented surgery of the neck or low back.
排除标准
- •Patients undergoing surgery for malignancy or trauma are excluded.
- •non Dutch speaking patients
- •pregnancy
研究组 & 干预措施
Stop smoking
patients are stimulated to stop smoking, using the Sine Fuma program. after 4 weeks nicotine in urine will be tested. if stopped: planned for surgery. 4 weeks after surgery nicotine in urine is checked again. will be planned for surgery and evaluated
干预措施: Stop smoking (Behavioral)
Continues smoking
will be planned for surgery and evaluated
干预措施: Stop smoking (Behavioral)
Does not smoke
will be planned for surgery and evaluated
结局指标
主要结局
ODI or NDI
时间窗: baseline, 2, 6 and 12 months post surgery
Oswestry Disability Index (lumbar spine) or Neck Disability Index (neck surgery), ranging from 0 (best) to 100 (worst)
次要结局
- perceived recovery(2, 6 and 12 months post surgery)
- HADS(baseline, 2, 6 and 12 months post surgery)
- EuroQol(baseline, 2, 6 and 12 months post surgery)
- VAS leg or arm pain(baseline, 2, 6 and 12 months post surgery)
- radiological evaluation for fusion(6 and 12 months after surgery)
研究者
C.L.A.Vleggeert-Lankamp
MD MSc PhD
Leiden University Medical Center