Yu Zheng1, Mao Mao1, Meifang Ji2, Qiugang Zheng2, Liang Liu3, Zhigang Zhao3, Haiming Wang4, Xiangyang Wei4, Yulong Wang5, Jiamin Chen5, Huiqing Zhou6, Qiaoqiao Liang6, Ying Chen1, Xintong Zhang1, Lu Wang1, Yihui Cheng1, Xiu Zhang1, Meiling Teng1, Xiao Lu7. 1. Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China. 2. Department of Rehabilitation Therapy, the Second Affiliated Hospital of Hainan Medical University, No. 368 Yehai Road, Haikou, 570100, China. 3. Department of Rehabilitation Medicine, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, China. 4. Department of Rehabilitation Medicine, the First Affiliated Hospital of Zhengzhou University, No. 1 East of Jianshe Road, Zhengzhou, 450052, China. 5. Department of Rehabilitation Medicine, Shenzhen Dapeng New District Nan'ao People's Hospital, No. 6 Renmin Road, Dapeng New District, Shenzhen, 518000, China. 6. Department of Rehabilitation Therapy, Taizhou Enze Medical Center, Enze Hospital, No. 1 East of Tongyang Road, Taizhou, 318050, China. 7. Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China. luxiao1972@163.com.
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.
RCT Entities:
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.
Entities:
Keywords:
Enhanced recovery after surgery; Health-related quality of life; Lung cancer surgery; Multicenter randomized controlled trial; Post-operative complication incidence; Pulmonary function; Pulmonary rehabilitation
Authors: Caroline Himbert; Nicole Klossner; Adriana M Coletta; Christopher A Barnes; Joachim Wiskemann; Paul C LaStayo; Thomas K Varghese; Cornelia M Ulrich Journal: Crit Rev Oncol Hematol Date: 2020-09-13 Impact factor: 6.312