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NCT Number: NCT06443203

Multimodal Prehabilitation in Colorectal Cancer Patients

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Prehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

Ferrara, 44123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trimodal prehabilitation

Other

Trimodal prehabilitation program (4-week physical exercise before surgery, nutritional optimization, and psychological support) in patients undergoing ERAS colorectal resection for cancer

Primary outcomes

  1. Postoperative functional capacity

    Time frame: 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 outcomes

  1. Post-operative complications

    Time frame: 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.

  2. Hospital length of stay

    Time frame: Within 30 days after surgery

    To evaluate the length of postoperative hospital stay

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications.

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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