To investigate patients' preoperative physical fitness, deconditioning due to hospitalisation with patients undergoing colorectal surgery for colorectal cancer. This study will serve as a control group for the prehabilitation study which will…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiopulmonary condition: VO2max test, steep ramp test, 6-min walk test.
Muscle strength: 1-RM test.
Secondary outcome
Quality of life questionnaires EORTC 29 and 30, SF-36, PHQ-9, GAD-7.
Nutrition status: food diary, NRS2002, PG-SGA.
Muscle composition: CT scan preoperatively (standard care)
Physical activity: accelerometer, CHAMPS score.
Background summary
Colorectal cancer (CRC) is the second most prevalent type of cancer with an
expected incidence of 15.000 patients in 2015 in the Netherlands. Surgery is
always an essential first step in treatment of CRC. Postoperative
complications occur in up to 50% of patients and are associated with higher
return of cancer and substantial increase in hospital costs. If patients
survive they have a substantial decrease in physical fitness resulting in a
lower Health Related Quality of Life (HRQoL). Moreover, after operation many
patients may need to undergo further treatment like chemotherapy. This is more
difficult if physical fitness is lowered.
The number and the severity of complications is closely related to preoperative
physical fitness, nutritional state and smoking behavior. Traditional
approaches have targeted the postoperative period for rehabilitation and
lifestyle changes. However, recent evidence shows that the preoperative period
is the optimal time frame for intervention. This time frame between diagnosis
and operation is restricted to 4-5 weeks. From a physiological point of view
and based on limited practical experience, it seems feasible to achieve
clinical relevant effects during this time frame. Only, if robust innovative
interventions of feeding and training are combined.
Study objective
To investigate patients' preoperative physical fitness, deconditioning due to
hospitalisation with patients undergoing colorectal surgery for colorectal
cancer. This study will serve as a control group for the prehabilitation study
which will start in the end of 2016. In 2016, patients will receive
individualized exercise training, nutritional support and a smoke cessation
program.
This control group will tell if a preoperative intervention could lead to
improved functional capacity preoperatively, compared to patients without a
preoperative intervention. Baseline information is needed to develop and
implement the right intervention for further research.
Research questions:
1) What is the functional capacity of patients undergoing colorectal surgery
for colorectal cancer?
2) Is the preoperative physical status related to postoperative complications?
3) Could patients' functional capacity be improved preoperatively?
Study design
Patients will be asked for participation when diagnosis of colorectal cancer is
performed. Four quality of life questionnaires will be performed. Moreover,
patients' physical status is measured using a VO2 max, steep ramp test, 1-RM
test and six minute walk test.
Study burden and risks
All possible risks will be documented and reported to the METC.
Possible risks:
The VO2max test carries a minor risk on cardiac events, although a negligible
risk.
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 with primary anastomosis.
Exclusion criteria
Multi organ resections, intraoperative radiotherapy, neoadjuvant therapy, inability to perform exercise.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL54547.015.15 |