Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.
Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, No. 368 Yehai Road, Haikou, 570100, China.
BMC Pulm Med. 2020 Feb 18;20(1):44. doi: 10.1186/s12890-020-1073-6.
Lung cancer surgery is associated with a high incidence of postoperative pulmonary complications (PPCs). Preliminary evidence suggests that ERAS processes can reduce overall incidence of PPCs as short- and long-term recovery improved by supporting units to adopt evidence-based care. However, the evidence is inconclusive due to insufficient high-level studies in this research field. No well-designed, adequately powered, randomized controlled trials (RCTs) have investigated the effects of pulmonary rehabilitation based ERAS program (PREP) on post-operative pulmonary complications, pulmonary function, and health related quality of life following lung cancer surgery.
The PREP trial is a pragmatic, investigator-initiated, multi-center, randomized controlled, parallel group, clinical trial. Five hundred patients scheduled for minimally invasive pulmonary resection at six hospitals in China will be randomized with concealed allocation to receive either i) a pre-operative assessment and an information booklet or ii) a pre-operative assessment, an information booklet, plus an additional education, a 30-min pulmonary rehabilitation training session and the post-operative pulmonary rehabilitation program. The primary outcome is incidence of PPCs defined with the Melbourne Group Scale diagnostic scoring tool. Secondary outcomes include incidence of cardiopulmonary and other complications, pulmonary function, cardiopulmonary endurance, muscle strength, activity level, health-related quality of life (HRQoL), pre- and post-operative hospital length of stay (LOS), and total hospital LOS.
The PREP trial is designed to verify the hypothesis that pulmonary rehabilitation based ERAS program reduces incidence of PPCs and improves pulmonary function and HRQoL in patients following lung cancer surgery. This trial will furthermore contribute significantly to the limited knowledge about the pulmonary rehabilitation based ERAS program following lung cancer surgery, and may thereby form the basis of future recommendations in the surgical community.
Chinese Clinical Trial Registry: ChiCTR1900024646, 21 July 2019.
肺癌手术后发生肺部并发症（PPCs）的概率较高。初步证据表明，通过支持单位采用循证护理，加速康复外科（ERAS）流程可以降低整体 PPCs 发生率，从而改善短期和长期的恢复情况。然而，由于该研究领域缺乏足够的高级别研究，证据尚不明确。没有设计良好、充分有力的随机对照试验（RCT）调查基于肺康复的 ERAS 方案（PREP）对肺癌手术后肺部并发症、肺功能和健康相关生活质量的影响。
PREP 试验是一项实用的、由研究者发起的、多中心、随机对照、平行组临床试验。将在中国 6 家医院接受微创肺切除术的 500 例患者以隐匿方式随机分配，接受术前评估和信息手册（i）或术前评估、信息手册、外加额外教育、30 分钟的肺康复训练课程和术后肺康复计划（ii）。主要结局是使用墨尔本组量表诊断评分工具定义的 PPCs 发生率。次要结局包括心肺和其他并发症、肺功能、心肺耐力、肌肉力量、活动水平、健康相关生活质量（HRQoL）、术前和术后住院时间（LOS）、总住院 LOS 的发生率。
PREP 试验旨在验证假设，即基于肺康复的 ERAS 方案可降低肺癌手术后患者 PPCs 的发生率，并改善肺功能和 HRQoL。该试验还将极大地丰富有关肺癌手术后基于肺康复的 ERAS 方案的有限知识，并可能为未来外科领域的建议提供依据。
中国临床试验注册中心：ChiCTR1900024646，2019 年 7 月 21 日。
