Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
- Locations
- 3
- Primary Endpoint
- Postoperative complications
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients (age > 18 years) scheduled for elective gastrointestinal surgery for cancer.
- •Signed informed consent
Exclusion Criteria
- •Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:
- •acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis)
- •severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 <50% pred, end-stage kidney or liver disease);
- •American Society of Anesthesiologists (ASA) physical status classes 4-
- •disabling orthopedic and neuromuscular disease.
- •psychosis, dementia;
- •symptomatic anemia.
- •Pregnancy
Arms & Interventions
Prehabilitation
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.
Intervention: Multimodal prehabilitation Program (Behavioral)
Control group
Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)
Outcomes
Primary Outcomes
Postoperative complications
Time Frame: Evaluation of severe post-operative complications within 30 days
Reduction of incidence of postoperative complications.
Secondary Outcomes
- Proportion of patients returning to preoperative functional walking capacity(30 days after surgery, 90 days follow up after surgery)
- Lenght of hospital stay(30 days after surgery)
Investigators
Giovanni Landoni
Associate Professor
Università Vita-Salute San Raffaele