Prehabilitation in oncological patients undergoing major gastrointestinal surgery: rationale and design of the PROGRESS trial

BACKGROUND: Preliminary evidence suggests that multimodal prehabilitation may reduce postoperative complications in patients undergoing cancer surgery. However, its true effectiveness has yet to be fully demonstrated, and there are still significant gaps in knowledge that need to be addressed. METHODS: This is a two-arm, multicenter, randomized controlled trial including 400 adult oncological patients undergoing major gastrointestinal surgery. Patients are randomized with a 1:1 allocation ratio either to receive a multimodal prehabilitation program in addition to standard care or standard care alone. The prehabilitation program consists of four weeks of intervention including exercise training, nutritional support, and psychological counseling. The standard of care is delivered in accordance with the Enhanced Recovery After Surgery (ERAS) pathways. RESULTS: The trial is ongoing and currently recruiting. The primary outcome is the rate of patients experiencing major postoperative complications within 30 days after surgery. We hypothesize that prehabilitation will reduce this rate from 40% to 25%. Secondary outcomes include the time of functional recovery, length of hospital stay, and complication severity. CONCLUSION: The PROGRESS trial will provide data to assess whether a prehabilitation program can reduce major postoperative complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov with the trial identification NCT06404489.