MedPath

Multimodal prehabilitation program in colorectal cancer patients to improve functional capacity and reduce postoperative complications.

Recruiting
Conditions
bowel cancer
colorectal neoplasms
10017990
10017991
Registration Number
NL-OMON50479
Lead Sponsor
Maxima Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

All adult patients undergoing elective colorectal surgery for colorectal cancer

Exclusion Criteria

Metastatic disease known preoperatively
Chronic renal failure (dialysis or creatinine >250 micromol)
ASA score of 4 or higher
Cognitive disabilities
Inability to perform exercise
Illiteracy (ability to read and understand Dutch written language)
Second primary tumour other than colorectal carcinoma simultaneously diagnosed
Not able to delay surgery for 4 weeks, due to for example clinical signs of
obstruction or short-course neo-adjuvant radiotherapy directly followed by
surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Postoperative complications determined by the comprehensive complication index<br /><br>(CCI).<br /><br>Functional capacity measured by the 6MWT.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>VO2-max test, sit-to-stand test, hand-grip strength, stair climb test.<br /><br>Health related quality of life determined by the SF-36, EORTC QLQCR29 and EORTC<br /><br>QLQC30.<br /><br>Activity questionnaire, GAD-7, PHQ-9, fried frailty score, food diary.<br /><br>Activity (accelerometer), anthropometry (body composition).<br /><br>Study compliance.<br /><br>Length of hospital stay, 30 day morbidity and mortality.<br /><br>Cost-effectiveness analysis.</p><br>
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