Multimodal Prehabilitation in Colorectal Cancer Patients

University Hospital of Ferrara

Status: Active, not recruiting

Conditions: Colon Cancer; Prehabilitation

Treatments: Other: Trimodal prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06443203

849/2019/Sper/AUSLFe

RF-2018- 12367272 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Trimodal prehabilitation

Experimental group

Description:

physical exercise, psychological support and nutritional optimization 4-weeks before surgery

Treatment:

Other: Trimodal prehabilitation

control group without preoperative prehabilitation

No Intervention group

Description:

Patients no receiveing prehabilitation and undergoing standard rehabilitation alone after surgery