Colon Cancer, Prehabilitation
Conditions
Keywords
prehabilitation, colorectal surgery, functional capacity, six-minute walking test, post-operative outcomes
Brief summary
Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients' post-operative convalescence and facilitate their return to functional activities. In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.
Detailed description
This study aims to determine the effect of prehabilitation on patients' functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.
Interventions
Trimodal prehabilitation program (4-week physical exercise before surgery, nutritional optimization, and psychological support) in patients undergoing ERAS colorectal resection for cancer
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of age >18 years; * elective colorectal resection for colonic cancer.
Exclusion criteria
* metastatic disease; * severe walking impairments; * renal failure stage >2; * ASA score >3; * preoperative chemo-radiation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative functional capacity | From enrollment to the end of treatment at 8 weeks after surgery | The primary outcome for functional capacity was measured by the 6-Minute Walking Test (6MWT), chosen as a validated, objective measure of colorectal surgery recovery integrating all components of physical activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | Within 30 days after surgery | To evaluate post-operative complications, the Clavien-Dindo classification has been used as a combined measure of morbidity and mortality. |
| Hospital length of stay | Within 30 days after surgery | To evaluate the length of postoperative hospital stay |
Countries
Italy
Outcome results
None listed