Author:
Zheng Yu,Mao Mao,Ji Meifang,Zheng Qiugang,Liu Liang,Zhao Zhigang,Wang Haiming,Wei Xiangyang,Wang Yulong,Chen Jiamin,Zhou Huiqing,Liang Qiaoqiao,Chen Ying,Zhang Xintong,Wang Lu,Cheng Yihui,Zhang Xiu,Teng Meiling,Lu Xiao
Abstract
Abstract
Background
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.
Methods
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.
Discussion
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.
Trial registration
Chinese Clinical Trial Registry: ChiCTR1900024646, 21 July 2019.
Publisher
Springer Science and Business Media LLC
Subject
Pulmonary and Respiratory Medicine