To design, implement and test a multimodal prehabilitation program in order to lower the complication rate and improve recovery rate for patients undergoing colorectal surgery for colorectal cancer by enhancing functional capacity (cardiopulmonary…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative complications determined by the comprehensive complication index
(CCI).
Functional capacity measured by the 6MWT.
Secondary outcome
VO2-max test, sit-to-stand test, hand-grip strength, stair climb test.
Health related quality of life determined by the SF-36, EORTC QLQCR29 and EORTC
QLQC30.
Activity questionnaire, GAD-7, PHQ-9, fried frailty score, food diary.
Activity (accelerometer), anthropometry (body composition).
Study compliance.
Length of hospital stay, 30 day morbidity and mortality.
Cost-effectiveness analysis.
Background summary
Colorectal cancer is the second most prevalent type of cancer in the world with
over 800.000 patients diagnosed yearly. Colorectal surgery is the most
essential step in curative treatment of this disease. In up to 50% of patients
undergoing colorectal surgery complications occur postoperative. This leads to
an increase of hospitalization length, an increase in health care costs to
almost 200%, a higher morbidity and mortality rate and a lower health related
quality of life.
It is known that the number and the seriousness of complications is highly
correlated to patients' preoperative health status. This health status is
highly correlated tot nutritional state, smoking behaviour and functional
excercise capacity. Colorectal cancer patients often have a poor lifestyle en
often develop problems with nutritional state, which may aggravate
deconditioning and muscle wasting. This implies that especially in this group
of patients there is much room for improvement and so seems appropriate to test
if a prehabilitation program leads to a decrease of complications.
Study objective
To design, implement and test a multimodal prehabilitation program in order to
lower the complication rate and improve recovery rate for patients undergoing
colorectal surgery for colorectal cancer by enhancing functional capacity
(cardiopulmonary capacity, muscle strength, nutritional state and smoking
behaviour) preoperatively.
Study design
In this international multicenter, prospective, randomized controlled trail
patients will be allocated an intervention group, receiving 4 weeks
prehabilitation or the control group receiving standard care. Both groups
obtain perioperative care following ERAS guidelines.
Intervention
Prehabilitation group will receive supervised exercise training by a
physiotherapist/kinesiologist, three times a week during 4 weeks. Additional
protein supplements (daily after training and before sleep) and (multi)vitamins
will be supplied. Every patient in the intervention group will receive an
intake with a trained member of the research team and when indicated, a
referral to the psychologist. A dietician provides dietary advice and advice on
adequate protein intake to improve nutritional status.
Study burden and risks
All possible risks will be documented and reported to the METC.
De VO2-max test has a very small risk of cardiologic complications. By
measurement of cardiopulmonary capacity of patients one can rule on condition
progress in more detail. Also, it gives additional information about potential
present heart and/or lung disease and overall cardiopulmonary capacity. This
gives a better insight in surgical risk and it makes it possible to lower this
surgical risk by adjustments preoperatively.
Potential benefits are improvement in cardiopulmonary fitness, muscle strength
and nutritional status. Also improvement in coping with disease and related
anxiety and stress. These elements might result in an improved postoperative
recovery and less postoperative complications. This advantage is for all
patients participating in the study since it is not part of normal care.
De Run 4600
veldhoven 5500MB
NL
De Run 4600
veldhoven 5500MB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
Other | NL5784 |
CCMO | NL58281.015.16 |
OMON | NL-OMON21887 |