Multimodal prehabilitation combined with perioperative enhanced recovery after surgery care for older patients undergoing spinal fusion surgery in China: protocol for a multicentre randomised controlled trial (PRACTICE trial)

Abstract

IntroductionBesides 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.Methods and analysisThis 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.Ethics and disseminationThis 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.Trial registration numberNCT06140797.