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The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery.
Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | Prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. |
|
| Control group | No Intervention | Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation Program | Behavioral | 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. The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Reduction of incidence of postoperative complications. | Evaluation of severe post-operative complications within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lenght of hospital stay | Reduction of lenght of hospital stay in treatment group | 30 days after surgery |
| Proportion of patients returning to preoperative functional walking capacity | Improving return to basal functional preoperative capacity |
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Inclusion Criteria:
Exclusion Criteria:
Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria | Cagliari | Sardinia | Italy | |||
| IRCCS San Raffaele Scientific Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10927999 | Background | Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available. | |
| 19808837 | Background | Bautmans I, Njemini R, De Backer J, De Waele E, Mets T. Surgery-induced inflammation in relation to age, muscle endurance, and self-perceived fatigue. J Gerontol A Biol Sci Med Sci. 2010 Mar;65(3):266-73. doi: 10.1093/gerona/glp145. Epub 2009 Oct 6. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 30 days after surgery, 90 days follow up after surgery |
| Milan |
| 20132 |
| Italy |
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| 41621468 | Derived | Oliva FM, Turi S, Veneziano M, D'Amico F, Passuello N, Notarianni L, Fiorindi C, De Piccoli N, Ripamonti L, Fossati L, Gualtierotti M, Ghezzi M, Vecchiato M, Pontillo D, Priolo S, Marchetti C, Sandona D, Cicero P, Nicastro V, Fumagalli A, Sarzo G, Kozhan P, Pecorelli N, Pieri M, Puccetti F, Foti S, Tettamanti A, Palumbo D, Basile G, Marmiere M, Fresilli S, Labanca R, Pruna A, Pasin L, Putzu A, Romero CS, Donadello K, Sardo S, Bove T, Nespoli L, Baldini G, Finco G, Vignali A, Beretta L; PROGRESS Study Group. Prehabilitation in oncological patients undergoing major gastrointestinal surgery: rationale and design of the PROGRESS trial. Contemp Clin Trials. 2026 Mar;162:108249. doi: 10.1016/j.cct.2026.108249. Epub 2026 Jan 31. |