Multimodal intensive prehabilitation in high impact surgery to reduce postoperative complications
Recruiting
- Conditions
- colon cancer, rectal cancer, esophageal cancer, liver metastases from colorectal cancer, pancreato-biliary cancer, peritoneal carcinomatosis from colorectal cancer, retroperitoneal sarcoma, abdominal aortic aneurysm, renal cancer, bladder cancer, supratentorial meningioma, hip arthrosis, knee or hip arthroplasty failure, osteosarcoma, pulmonary cancer, thoracic aortic aneurysm, head and neck cancer, mouth cancer, breast reconstruction, ovarian cancer, endometrial cancer, vulvar cancer
- Registration Number
- NL-OMON28368
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2830
Inclusion Criteria
oAdult patients (>16 years),
oscheduled for elective high impact surgery,
oindependent of (neo-) chemotherapy and/or radiotherapy,
oobtained written informed consent.
Exclusion Criteria
oParalytic or immobilized patients who are not able to complete exercise intervention,
opremorbid conditions or orthopedic impairments which contraindicate exercise,
oinability to undergo the intervention due to lack of understanding or instructability (e.g. cognitive disability or illiteracy (disability to read and understand Dutch)).
ounstable cardiac or respiratory disease which contraindicate exercise,
orenal failure stage 3 or higher which contraindicate protein supplementation
oASA score 4 or higher,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effects of a multimodal intensive prehabilitation program a high-risk patient group on complications (Clavien-Dindo score and Comprehensive Complication Index (CCI) score)
- Secondary Outcome Measures
Name Time Method To investigate the effects of multimodal intensive personalized prehabilitation on an: <br>-Individual patient’s level, i.e. length of hospital stay (in days), physical fitness (estimated VO2 peak, indirect 1 repetition measures, physical activity), nutritional status (body weight, fat-free mass), mental health (HRQoL), intervention adherence<br>-Mechanistic level, i.e. innate immune response (degree of immunoparalysis)<br>-Hospital-efficiency level: costs due to complications, costs due to length of hospital stay, budget impact, cost-effectiveness<br>-Macro-economic level: changes in patients volumes, shifts in care between 2nd and 1st line healthcare