Hungarian hospital starts a clinical trial of long term effect of trimodal prehabilitation compared to ERAS in colorectal cancer surgery

Photo by Jennifer Latuperisa-Andresen

St. Borbala Hospital in collaboration with Biological Research Centre (Szeged, Hungary) is enrolling patients into the clinical trial investigating the long term effect of trimodal prehabilitation compared to ERAS in colorectal cancer surgery (Prehab_2).

The hospital is recruiting patients in the following locations Department of Surgery, St. Borbala Hospital (Tatabánya, Hungary, 2800) and St. Borbala Hospital (Tatabánya, Hungary, 2800).

Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.

ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.

Trimodal Prehabilitation Program is a recently introduced preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.

The focus of a clinical study are

Procedure: Trimodal rehabilitation + ERAS (Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.)

And

Procedure: ERAS + nutritional prehabilitation (Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.)

This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.

Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.

On 7 September, first participant was enrolled into this clinical study. The estimated study completion date is September 7, 2030.

The population that are excluded from participation:

• emergency operation;
• palliative operation;
• non-colorectal, second malignancy;
• pregnancy;
• patient not giving consent

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04595604