Fit4Surgery: multimodal intensive prehabilitation in high impact surgery - a stepped-wedge cluster randomized trial

Recruiting

Conditions: high impact chirurgie voor colorectaal kanker, oesofagus kanker, lever metastasen door colorectaal kanker, pancreas kanker, peritonitis carcinomatosa, abdominale aorta aneurysma, niercel kanker, blaas kanker, meningeoom (supratentorieel), heup arthrose, osteosarcoom, longkanker, thoracale aorta aneurysma, hoofd-hals kanker, mond kanker, borst reconstructie, ovarium kanker of endometriose
high impact surgery
high risk abdominal surgery

Registration Number: NL-OMON49362

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 2830

Inclusion Criteria

Patients >16 years,
scheduled for elective high impact surgery,
independent of (neo-) chemotherapy and/or radiotherapy,
obtained written informed consent.

Exclusion Criteria

Metastatic disease known preoperatively (exemption colorectal carcinoma liver
metastases and peritoneal metastases),
paralytic or immobilized patients who are not able to complete exercise
intervention,
premorbid conditions or orthopedic impairments that contraindicated exercise,
cognitive disabilities,
unstable cardiac or respiratory disease,
renal failure stage 3 or higher,
ASA score 4 or higher,
illiteracy (disability to read and understand Dutch).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study investigates the effect of prehabilitation on postoperative<br /><br>complications</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>This study investigates the effect of prehabilitation on:<br /><br>- Individual patient*s level: length of stay, physical fitness, nutritional<br /><br>status, mental health, intervention adherence<br /><br>- Mechanistic level: innate immune response<br /><br>- Hospital-efficiency level: costs due to complications, costs due to length of<br /><br>hospital stay, budget impact analysis, cost-effectiveness<br /><br>- Macro-economic level: changes in patients volumes, shifts in care between 2nd<br /><br>and 1st line healthcare</p><br>