Multimodal Prehabilitation in Colorectal Cancer Patients

Not Applicable

Active, not recruiting

• Conditions: Prehabilitation; Colon Cancer
• Interventions: Other: Trimodal prehabilitation

• Registration Number: NCT06443203
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2021-06-15
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-06-02
• Study Completion: 2026-04-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trimodal prehabilitation	Trimodal prehabilitation	physical exercise, psychological support and nutritional optimization 4-weeks before surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hospital length of stay	Within 30 days after surgery	To evaluate the length of postoperative hospital stay
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.

Trial Locations

Locations (1)

Unità Operativa Qualità, Accreditamento, Ricerca organizzativa; 🇮🇹 Ferrara, Italy