This is a 2-arm randomized multicentric controlled trial to test the efficacy of a
personalized, multidisciplinary, preoperative conditioning program to reduce severe
complications and facilitate recovery in patients undergoing major oncological
gastrointestinal surgery.
400 patients will be randomized (ratio 1:1) and allocated either to the intervention
group (Prehabilitation), or to the control group (which will be treated according to
usual standard of care within Enhanced Recovery After Surgery (ERAS) pathways).
Multimodal prehabilitation is a preoperative intervention which includes exercise
training, nutritional therapy and anxiety reducing techniques, aimed at preventing or
attenuating surgery-driven functional decline.
The primary objective is to evaluate the effect of a multimodal program of
prehabilitation on postoperative severe complications.
Secondary outcomes include time to functional recovery, length of hospital stay,
complication severity, proportion of patients returning to preoperative functional
walking capacity and self-reported activity status and generic health related quality of
life at 30 days after surgery.
Included patients will be randomized and allocated either to the intervention group,
which will receive 4 weeks of prehabilitation, or to the control group, which will
receive no prehabilitation. All patients will be reassessed the day before surgery, 30
days and 3 months after surgery.
Patients enrolled in treatment group will not receive any additional medication but only
a multimodal program to optimize their preoperative functional capacity.
Within 30 days prior to scheduled surgery, participants of both groups will undergo a
specialized multidisciplinary assessment with a physician, a certified physiotherapist,
registered dietitian and psychology trained personnel. All tests will be performed
following international guidelines and standardized verbal instructions. A tailored
intervention will be prescribed if specific physical, nutritional or psychological
impairments will be identified during the assessment phase. Based on the data obtained
during the multimodal assessment, different domains and levels of care will be
prescribed, focusing on exercise training, and/or nutrition optimization, and/or
distress-coping techniques. Different combinations of three domains will be utilized to
maximize their synergistic anabolic effect.
Statistical analysis will be performed according to study sites, type of surgery
(esophageal, gastric, colonic, rectal) and neoadjuvant treatment.
