The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Incidence of any complications
研究概览
简要总结
As China's society ages faster, the number of elderly patients undergoing spinal fusion surgery will gradually increase. Since elderly patients are at higher risk of postoperative complications than younger patients, minimizing complications after spinal fusion becomes a priority in postoperative rehabilitation. The purpose of this prospective cohort study is to develop an enhanced recovery after surgery program including individualized perioperative smoking cessation strategies in Chinese elderly undergoing spinal fusion.
详细描述
With the aging society, elderly population in China has reached 172 million (12%) in 2020 and is predicted to rise to 336 million (26%) by 2050. This will be accompanied by more elderly people with degenerative spinal diseases who may become candidates for spinal surgery (e.g., spinal fusion). Compared with younger patients, elderly patients are more likely to experience complications after spinal fusion (e.g., 9% and 14% for <65 and ≥ 65 years old in lumbar fusion), which may lead to adverse patient outcomes including worse functional outcomes and satisfaction and increased revision surgery.
Recently, enhanced recovery after surgery (ERAS) program for spinal fusion including the pre-, intra-, and post-operative care interventions has been developed. Previous studies have shown that ERAS has multiple benefits for elderly undergoing spinal fusion, such as reduced complications and shorter hospital stays. However, the preoperative smoking cessation protocols varied widely between studies (e.g., at least 4 weeks, 3 months, and 2 weeks before surgery), which may be due to a lack of evidence.
Therefore, we plan to conduct a prospective study to improve the perioperative smoking cessation strategy of ERAS and establish an evidence-derived protocol.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years old or more;
- •Patients who plan to undergo spinal fusion with ERAS program;
- •Patients who agreed to participate in this study.
排除标准
- •Patients who cannot understand the study content or have difficulty communicating;
- •Patients with a history of spinal fusion surgery;
- •Patients with spinal fractures, spinal tumor, or spinal infections;
- •Patients with congenital spinal deformity;
- •Patients who were unable to complete at least 6 months of follow-up;
- •Patients with incomplete clinical information.
结局指标
主要结局
Incidence of any complications
时间窗: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Any major or minor complications occurs during this study will be reported.
次要结局
- Prevalence of postoperative pain(From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.)
- Level of quality of life(From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.)
- Length of hospital stay(From the date of admission until the date of discharge or the date of death from any cause, whichever come first, assessed up to 6 months.)
- Prevalence of pain-related disability(From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.)