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 longterm 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.

Outcomes of enhanced recovery after surgery in lung cancer: A systematic review and meta-analysis

“…Research by Huang et al (36) showed that compared with traditional perioperative care, ERAS reduced postoperative pain and shortened chest tube indwelling time. Furthermore, previous studies have found a substantial difference in quality of life between the ERAS program and standard care, which indicates that ERAS is beneficial (71,72). There is also evidence that the LOS of patients treated with the ERAS program is shorter (73).…”

Effects of enhanced recovery after surgery plus pulmonary rehabilitation on complications after video-assisted lung cancer surgery: a multicentre randomised controlled trial

“…It was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of the coordinating centre (2019-SR-360). The original protocol was published in 202019; any deviations are documented in online supplemental material 1.…”

“…Patients scheduled for lung cancer surgery were screened for eligibility. Consolidated criteria for patient enrolment are summarised in table 1 19. Eligible patients were then invited to participate in the trial.…”

Recent advances in postoperative pulmonary rehabilitation of patients with non‑small cell lung cancer (Review)

“…Although thoracoscopic lobectomy is more conducive to patient recovery, the probability of various complications after thoracoscopic surgery remains high at 15.8-31.7%, mainly involving pulmonary air and pleural effusion such that, when taking into account the different stages of cancer, 25-70% of patients eventually relapse (11)(12)(13). The complication rate for thoracoscopic lobectomy due to sputum retention and weakened respiratory muscle strength is as high as 19-59%, which seriously affects patient recovery (14).…”