Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial)

• Published in: BMJ open Vol. 13; no. 1; p. e070253
• Main Authors: Beilstein, Christian M, Krutkyte, Gabija, Vetsch, Thomas, Eser, Prisca, Wilhelm, Matthias, Stanga, Zeno, Bally, Lia, Verra, Martin, Huber, Markus, Wuethrich, Patrick Y, Engel, Dominique
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 03.01.2023; BMJ Publishing Group
• Series: Protocol
• Subjects: Aged; Anaesthesia; Frailty; Humans; Mortality; Multicenter Studies as Topic; Older people; Physical Fitness; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Preoperative Care - methods; Preoperative Exercise; Prospective Studies; Randomized Controlled Trials as Topic; Surgical outcomes; geriatric medicine; clinical trials; surgery
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-070253

The global volume of surgery is growing and the population ageing, and economic pressure is rising. Major surgery is associated with relevant morbidity and mortality. Postoperative reduction in physiological and functional capacity is especially marked in the elderly, multimorbid patient with low fitness level, sarcopenia and malnutrition. Interventions aiming to optimise the patient prior to surgery (prehabilitation) may reduce postoperative complications and consequently reduce health costs. This is a multicentre, multidisciplinary, prospective, 2-arm parallel-group, randomised, controlled trial with blinded outcome assessment. Primary outcome is the Comprehensive Complications Index at 30 days. Within 3 years, we aim to include 2×233 patients with a proven fitness deficit undergoing major surgery to be randomised using a computer-generated random numbers and a minimisation technique. The study intervention consists of a structured, multimodal, multidisciplinary prehabilitation programme over 2-4 weeks addressing deficits in physical fitness and nutrition, diabetes control, correction of anaemia and smoking cessation versus standard of care. The PREHABIL trial has been approved by the responsible ethics committee (Kantonale Ethikkomission Bern, project ID 2020-01690). All participants provide written informed consent prior to participation. Participant recruitment began in February 2022 (10 and 8 patients analysed at time of submission), with anticipated completion in 2025. Publication of the results in peer-reviewed scientific journals are expected in late 2025. NCT04461301.