Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT06443203
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:
NCT06443203
Study Brief:
Protocol Section:
NCT06443203