Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443203
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-22
Brief Title:
Multimodal Prehabilitation in Colorectal Cancer Patients
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients39 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
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 patients39 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 N56 or control group receiving no prehabilitation N56 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RF-2018- 12367272 | OTHER_GRANT | Italian Ministry of Health | None |