The primary objective of the research is to measure the effect of a 3 week prehabilitation program on the postoperative complications in patients with an anaerobic threshold of
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this research are the postoperative complications
within 30 days after elective colorectal surgery. We expect a decrease in
postoperative complications from 73 percent to 33 percent in the
prehabilitation group.
Secondary outcome
The secondary objectives are to observe what happens with the anaerobic
threshold in the intervention group and the control group. Also the effect of
the prehabilitation program on length of stay in hospital will be observed. The
value of a limited geriatric assessment in this patients group will also be
investigated.
Background summary
Abdominal surgical interventions in elderly patients with colorectal cancer are
increasing. According to the Dutch Surgcial Colorectal Audit, 33 percent of the
colorectal patients have one ore more postoperative complications after
elective colon surgery. The elderly in particular are prone to postoperative
complications. Studies show that an anaerobic threshold below 11 ml/kg/min is a
good predictor of postoperative complications. Patients with an anaerobic
threshold below 11 ml/kg/min are considered high-risk. Current studies show
that high-risk patients who were placed on an exercise program before elective
surgery, improve their cardiopulmonary capacity. Based on an interim analysis,
our hypothesis is that preoperative training of high-risk patients with
colorectal cancer reduces the postoperative complication rate from 73 to 33
percent.
Study objective
The primary objective of the research is to measure the effect of a 3 week
prehabilitation program on the postoperative complications in patients with an
anaerobic threshold of <11 ml/kg/min who*ll undergo elective coloretal surgery
for colorectal cancer.
The secondary objectives are to observe what happens with the anaerobic
threshold and inspiratory muscle strength in the intervention group and the
control group. Also the effect of the prehabilitation program on the length of
stay in hospital will be observed.
Study design
This study is a multicenter prospective randomized controlled trial. The
interventions, prehabilitation versus usual care, are randomly assigned to the
patients.The effect of prehabilitation versus no prehabilitation will be
compared. This trial will run from fall 2013 untill all patients are included,
this will probably be in December 2018. The study will take place in Medisch
Spectrum Twente in Enschede and ZGT in Almelo.
Intervention
27 patients will receive 3 weeks of physiotherapy before surgery. The
physiotherapy consists of one hour cardiopulmonary training on an exercise
bicycle, three times a week. The control group will receive regular health
care.
Study burden and risks
Only patients in the intervention group will in all likelihood benefit from the
study. Those in the control group will not benefit. The risk for adverse events
in this study is negligible. The patients will have to invest some extra time
during this study. They have to perform a cardiopulmonary exercise test twice,
which will take 1,5 hour. The intervention group will have to participate in
the physiotherapy training for 9 hours.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- * 60 years
- Colon cancer or rectal cancer
- Undergoing elective colorectal surgery
- Having a life expectancy of more then 6 months
- Has given informed consent to participate in the study
- Metabolic equivalent score of *7 on the Veterans Specific Activity Questionnaire
- Anaerobic threshold < 11 ml/kg/min after the first CPET
- Able to perform a cardiopulmonary exercise test
- Will be operated at Medisch Spectrum Twente at Enschede
- Will be treated at a private physiotherapy practice in the catchment of the Medisch Spectrum Twente Hospital
- Patients with grade I, II or III dysplasia in a colorectal polyp requiring colorectal resection
Exclusion criteria
- Anaerobic threshold * 11 ml/kg/min after the first CPET
- Not capable to perform a cardiopulmonary exercise test
- Undergoing emergency colorectal surgery
- Meeting the absolute and/or relative exclusion criteria from the CPET protocol used in Medisch Spectrum Twente.
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 |
---|---|
CCMO | NL45001.044.13 |
Other | trialregister NTR 4032 |
OMON | NL-OMON26329 |