Project Details
Projekt
PREHAB-Trial: Multimodal prehabilitation reduces postoperative complications in high-risk patients undergoing major gastrointestinal cancer surgery – a multicentre, randomised, controlled trial
Applicant
Professor Dr. Robert Schier
Subject Area
Anaesthesiology
Term
since 2026
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 558914691
In Germany around 85,000 patients have to undergo surgery every year for gastrointestinal cancer. The incidence of postoperative complications, especially in a group of high-risk patients with previous cardiovascular disease and pre-treated neoadjuvant therapy, is a major problem. The aim of oncological treatment is not only an effective surgical therapy, but also an improvement in postoperative survival and quality of life. In this context, a preoperative improvement of patients' functional capacity, nutritional status and psychological condition is of decisive importance for the postoperative result. Modern concepts such as preoperative rehabilitation (prehabilitation) utilize the preoperative phase to improve the patient's clinical condition and to adequately prepare him for the stress of an operation. So far, however, there is no homogeneous approach from comparable prehabilitation studies tested in a sufficiently large patient collective with the aim of reducing postoperative complications. In this multicenter, randomized, controlled study (n = 403) we analyse the effect of multimodal prehabilitation in relation to postoperative complications. The intervention group (n=202) will participate in supervised progressive exercise program conducted by professional sport therapist, consisting of three 50-min sessions per week. Each session will be divided in (i) a resistance exercise part, aiming to increase patients` strength and (ii) an endurance part aiming to improve patients` cardio-respiratory fitness. The control group will receive a usual care alone and will be explored via activity questionnaires (i.e. DASI and willingness to exercise). Key inclusion criteria will include 1) Age >=18/ <=80; 2) Candidate to elective major gastrointestinal cancer surgery (pelvic exenteration, cytoreductive surgery, esophagectomy, hepatectomy, pancreatectomy, rectum resection); 3) High risk for surgical complications defined by presence of comorbid disease such as deconditioning, heart disease, diabetes, renal impairment or morbid obesity; 4) Duke Activity Status Index score <40, 5) Schedule allowing for at least 4 weeks for intervention with multimodal prehabilitation prior to surgery. The primary endpoint of this study is the incidence of postoperative complications (according to Clavien-Dindo classification grade III-V), which has a prognostic significance for postoperative survival. We test the hypothesis that prehabilitation, conducted over a period of one month before surgery, lowers the incidence of postoperative complications when compared to the control group.
DFG Programme
Clinical Trials
