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Does a pulmonary rehabilitation based ERAS program (PREP) affect pulmonary complication incidence, pulmonary function and quality of life after lung cancer surgery? Study protocol for a multicenter randomized controlled trial.

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.

SUBMITTER: Zheng Y

PROVIDER: S-EPMC7029521 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Does a pulmonary rehabilitation based ERAS program (PREP) affect pulmonary complication incidence, pulmonary function and quality of life after lung cancer surgery? Study protocol for a multicenter randomized controlled trial.

Zheng Yu Y Mao Mao M Ji Meifang M Zheng Qiugang Q Liu Liang L Zhao Zhigang Z Wang Haiming H Wei Xiangyang X Wang Yulong Y Chen Jiamin J Zhou Huiqing H Liang Qiaoqiao Q Chen Ying Y Zhang Xintong X Wang Lu L Cheng Yihui Y Zhang Xiu X Teng Meiling M Lu Xiao X

BMC pulmonary medicine 20200218 1

<h4>Background</h4>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 ...[more]

PMID: 32070326

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Project description:Background:Several studies show that the enhanced recovery after surgery (ERAS) program reduces complications postoperatively and leads to faster recovery and shorter hospital stays. However, little is known about patients' self-reported health in an enhanced recovery context. The aim of this study was firstly to describe patient experiences of health within the concept of ERAS after colorectal (CR) surgery during a hospital stay and within 2?weeks of discharge. Secondly, to explore whether the ASA classification/co-morbidity, sex, and surgical method affect the patient's experience of health. Methods:Data were collected through the ERAS-HEALTH questionnaire, including two open-ended questions, and through telephone interviews postoperatively. Qualitative and quantitative analysis was used. Patients undergoing CR surgery (n = 80) were included from October 2016 to June 2018. Results:The patients had mainly positive experiences of their hospital stay as well as most of them felt comfortable coming home. However, experienced state of health is affected by factors like surgical method and co-morbidity. Improvements were desired concerning information, food/food intake, pain management, and environment. At home, the patients experienced a lack of information about food/food intake and ostomy care. Decreased appetite and difficulties with micturition were also described. The most troublesome symptom was postoperative fatigue (POF). Analysis of the ERAS-HEALTH questionnaire showed that patients with higher co-morbidity and those who underwent open surgery have a significantly worse experience of their health compared with patients who underwent laparoscopy. However, it seems that the surgical method affects postoperative health to a greater extent than co-morbidity. Conclusions:The patients reported many positive aspects and challenges when being cared for within the ERAS program. However, several improvements are needed to satisfy patient wishes regarding their care both in hospital and at home. Laparoscopic surgery affects patient state of health positively in several respects compared with open surgery.

Dataset Information

Does a pulmonary rehabilitation based ERAS program (PREP) affect pulmonary complication incidence, pulmonary function and quality of life after lung cancer surgery? Study protocol for a multicenter randomized controlled trial.

Publications

Does a pulmonary rehabilitation based ERAS program (PREP) affect pulmonary complication incidence, pulmonary function and quality of life after lung cancer surgery? Study protocol for a multicenter randomized controlled trial.

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