Multimodal prehabilitation (Fit4Surgery) in high-impact surgery to enhance surgical outcomes: Study protocol of F4S PREHAB, a single center stepped wedge trial

Background High-impact surgery imposes a significant physiological and functional burden and is associated with substantial postoperative morbidity. Multimodal prehabilitation has demonstrated a reduction in postoperative complications and enhanced functional recovery, mainly in abdominal cancer surgery. Common preoperative risk factors shared among patients undergoing high-impact surgery, extending beyond abdominal cancer surgery procedures, suggest the relevance of multimodal prehabilitation to a broader patient population. This stepped wedge trial primarily aims to examine the hospital-wide effect of multimodal prehabilitation, compared to standard preoperative care, on the occurrence and severity of postoperative complications. Secondary and tertiary endpoints include length of hospital stay, physical fitness, nutritional status, mental health, intoxications, and cost-effectiveness of the intervention. Methods The Fit4Surgery (F4S) PREHAB trial is a monocenter stepped wedge trial in an academic hospital. Adult patients, divided into 20 health clusters based on specific diagnoses, will be assessed for eligibility and receive usual preoperative care or multimodal prehabilitation. Patient enrollment commenced in March 2021 and continues up to and including April 2024. The intervention consists of a high-intensity exercise program, a nutritional intervention, psychological support, and smoking and alcohol cessation. The primary outcome will be measured by the Clavien-Dindo classification (grade II or higher) and the Comprehensive Complication Index (CCI). Discussion Multimodal prehabilitation potentially reduces postoperative complications and enhances functional recovery. This is the first study to determine the hospital-wide effect and cost-effectiveness of multimodal prehabilitation in patients across various surgical specialties.