Wang Shuai-Kang, Wang Peng, Wang Wei, Lu Shibao
Department of Orthopedics & Elderly Spinal Surgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital Capital Medical University, Beijing, China.
Department of Orthopedics & Elderly Spinal Surgery, Xuanwu Hospital Capital Medical University, Beijing, China.
BMJ Open. 2024 Dec 11;14(12):e088339. doi: 10.1136/bmjopen-2024-088339.
Besides the comorbid risk factors shared by older and younger patients, older individuals may also experience malnutrition, as well as cognitive or functional impairments. The accumulation of frailty and various geriatric syndromes in older individuals results in decreased physiological reserves, which makes the recovery process after spine surgery particularly challenging. Theoretically, combining the presurgery optimisation provided by a multimodal prehabilitation programme with the reduction of surgical stress provided by an enhanced recovery after surgery (ERAS) programme could improve postoperative recovery of older patients.
This is a prospective, multicentre, assessor-blinded, randomised controlled study. Patients who are 75 years of age or older and are scheduled for spinal fusion surgery will be enrolled on three academic medical centres. Regular preadmission education and perioperative ERAS care will be given to participants who were randomised to the control group. Participants randomised to the intervention group will receive multimodal prehabilitation combined with ERAS (PREERAS) management. We will include 164 patients with spinal fusion in three hospitals in China. All included patients will be followed for 90 days after surgery or until death. The primary outcome is the Comprehensive Complication Index (CCI), which ranges from 0 to 100, where a score of 100 indicates death due to complications. Secondary outcomes include length of stay and non-home discharge, rates of postoperative complications and unplanned readmission, North American Spine Society satisfaction, and Oswestry Disability Index/Neck disability index. Ninety-day CCI will be compared between groups using linear regression. Other continuous or categorical outcomes will be compared using linear or logistic regression.
This study has received ethical approval from the Xuanwu Hospital of Capital Medical University Ethics Committees (2024-088-001). The findings will be submitted to a peer-reviewed journal for publication.
NCT06140797.
除了老年和年轻患者共有的合并症风险因素外，老年人还可能出现营养不良以及认知或功能障碍。老年人中衰弱和各种老年综合征的积累导致生理储备下降，这使得脊柱手术后的恢复过程特别具有挑战性。从理论上讲，将多模式术前康复计划提供的术前优化与术后加速康复（ERAS）计划提供的手术应激减少相结合，可以改善老年患者的术后恢复。
这是一项前瞻性、多中心、评估者盲法、随机对照研究。年龄在75岁及以上且计划进行脊柱融合手术的患者将在三个学术医疗中心入组。随机分配到对照组的参与者将接受常规的入院前教育和围手术期ERAS护理。随机分配到干预组的参与者将接受多模式术前康复与ERAS（PREERAS）管理相结合的治疗。我们将纳入中国三家医院的164例脊柱融合患者。所有纳入的患者将在术后随访90天或直至死亡。主要结局是综合并发症指数（CCI），范围为0至100，其中100分表示因并发症死亡。次要结局包括住院时间和非回家出院、术后并发症和计划外再入院率、北美脊柱协会满意度以及奥斯威斯功能障碍指数/颈部功能障碍指数。将使用线性回归比较组间的90天CCI。其他连续或分类结局将使用线性或逻辑回归进行比较。
本研究已获得首都医科大学宣武医院伦理委员会的伦理批准（2024-088-001）。研究结果将提交给同行评审期刊发表。
NCT06140797。
