PRehabIlitatiOn with pReoperatIve exercise and educaTion for patients undergoing major abdominal cancer surgerY: protocol for a multicentre randomised controlled TRIAL (PRIORITY TRIAL)

Abstract

Background Radical surgery is the mainstream treatment for patients presenting with advanced primary or recurrent gastrointestinal cancers; however, the rate of postoperative complications is exceptionally high. The current evidence suggests that improving patients’ fitness during the preoperative period may enhance postoperative recovery. Thus, the primary aim of this study is to establish the effectiveness of prehabilitation with a progressive, individualised, preoperative exercise and education program compared to usual care alone in reducing the proportion of patients with postoperative in-hospital complications. The secondary aims are to investigate the effectiveness of the preoperative intervention on reducing the length of intensive care unit and hospital stay, improving quality of life and morbidity, and reducing costs. Methods This is a multi-centre, assessor-blinded, pragmatic, comparative, randomised controlled trial. A total of 172 patients undergoing pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy will be recruited. Participants will be randomly allocated to prehabilitation with a preoperative exercise and education program (intervention group), delivered over 4 to 8 weeks before surgery by community physiotherapists/exercise physiologists, or usual care alone (control group). The intervention will comprise 12 to 24 individualised, progressive exercise sessions (including aerobic/anaerobic, resistance, and respiratory exercises), recommendations of home exercises (16 to 32 sessions), and daily incidental physical activity advice. Outcome measures will be collected at baseline, the week prior to surgery, during the hospital stay, and on the day of discharge from hospital, and 1 month and 1 months postoperatively. The primary outcome will be the development of in-hospital complications. Secondary outcomes include the length of intensive care unit and hospital stay, quality of life, postoperative morbidity and costs. Discussion The successful completion of this trial will provide robust and high-quality evidence on the efficacy of a preoperative community- and home-based exercise and education intervention on important postoperative outcomes of patients undergoing major gastrointestinal cancer surgery. Trial registration This trial was registered prospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12621000617864) on 24th May 2021.

Functional outcomes following pelvic exenteration: results from a prospective cohort study

“…Mounting evidence supporting postoperative functional decline following exenterative surgery also warrants further research and implementation of preoperative interventions, such as prehabilitation [40][41][42][43][44]. In fact, we are currently planning a randomized control trial to examine the impact of prehabilitation on postoperative outcomes in the context of oncological surgery [45].…”

Preoperative exercise and prehabilitation

“…To put it in a nutshell, prehabilitation is capable of reducing certain postoperative complications [42] and shortening hospital length of stay [36,38,51,53]. However, current clarifying trials are ongoing [41 ▪ ,54] and critical appraisal is required to ensure high quality of prehabilitation and comparability of the target population. Whether multimodal prehabilitation has an impact on patients’ long-time quality of life specifically after major cancer surgery and whether clinical generalizability exists, must be clarified in future studies [55,56].…”

“…Prehabilitation is one of the growing interventional options in the field of anaesthesia and its effectiveness has been studied recently in several studies [7,38,39,41 & ,42 -44]. Especially the challenges in oncoanaesthesia with a patient population presenting to the operating room with increasing risk factors and at older age need alternative presurgical strategies in order to cope with the inflammatory burden linked to the surgical trauma.…”

Principles of enhanced recovery in gastrointestinal surgery

“…Notwithstanding, conflicting results from recent randomized studies failed to demonstrate clearly the added value of prehabilitation to ERAS, especially in colorectal surgery [ 68 , 69 ]. In consequence, further data from multicentric large-scale trials on major gastrointestinal surgery are upcoming [ 70 ].…”