The aim of the study is to gain more insights into the metabolic demand and possible changes thereof pre- and postoperatively. Additionally, data on aerobic fitness and activity levels will be gathered.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference of energy expenditure pre- and
postoperatively, as measured with doubly labelled water and indirect
calorimetry.
Secondary outcome
Additionally, aerobic fitness, physical activity level, metabolic factors in
blood, and postoperative complications will be assessed.
Background summary
Complication rates after major liver resections remain as high as 43%. Many
initiatives have been taken to reduce postoperative morbidity. As such,
prehabilitation programmes are increasingly used for patients undergoing major
abdominal surgery. Improvement of aerobic fitness has been proven to reduce
complication rates, especially in high-risk patients (those with a low
preoperative aerobic capacity). Different conceptual hypotheses exist of the
underlying mechanism of variability in postoperative complications and
prehabilitation response. One of the complementary rationales focusses on
homeostasis-allostasis before and after surgery, more specifically on the
preoperative aerobic capacity to meet postoperative metabolic demands. However,
more insight in postoperative metabolic demands (energy expenditure) during
in-hospital recovery from major abdominal surgery in relation to preoperative
resting metabolic demands and maximal aerobic capacity is essential to
understand the increase in metabolic demands coinciding with major surgery in
relation to the body*s reserve capacity. This information can be used to better
understand the rationale behind exercise prehabilitation, as well as to
optimize the content of preoperative treatment for unfit patients, for instance
by means of personalized prehabilitation programmes that might improve
postoperative outcomes.
Study objective
The aim of the study is to gain more insights into the metabolic demand and
possible changes thereof pre- and postoperatively. Additionally, data on
aerobic fitness and activity levels will be gathered.
Study design
The study will be a prospective observational study with thorough pre- and
postoperative measurements of energy expenditure. Energy expenditure will be
measured using the doubly labelled water method, as well as by indirect
calorimetry. To assess aerobic capacity, cardiopulmonary exercise testing will
be performed pre- and postoperatively. Additionally, accelerometers will be
used to evaluate pre- and postoperative physical activity levels . Blood
samples will be collected to analyze metabolic factors in the blood.
Study burden and risks
The study poses a low risk on the patients. Doubly labelled water has a low
burden (intake of doubly labelled water and collecting urine samples) and has
been proven safe for use in humans in many clinical studies. Therefore, the
risks associated with this measurement is very low. Indirect calorimetry to
determine pre- and postoperative resting energy expenditure is safe and has a
low participant burden (30 min of resting measurements in supine position at 5
different time points). Cardiopulmonary exercise testing will be performed 7
days before surgery and at hospital discharge under supervision of trained
professionals in safe circumstances. The risk for patients is considered to be
low. To monitor physical activity levels pre- and postoperatively during the
observational period (7 days preoperatively and 7 days postoperatively),
wearable sensors (accelerometers) will be used. The burden for patients is
minimal. Preoperatively there is one extra visit to the clinic. Overall, the
planned measurements will not pose low risk to patients. However, given the
intensity of assessments there might be a considerable burden for patients.
Universiteitssingel 50
Maastricht 6229HX
NL
Universiteitssingel 50
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
o Age >=18 years
o Scheduled for liver resection (>=3 segments) at the MUMC+
o Able to understand the Dutch language sufficiently to give consent and follow
orders during study assessments
Exclusion criteria
o Cirrhotic liver, Child Pugh B-C
o Unable or unwilling to perform CPET or indirect calorimetry
o Liver ablation as the primary treatment
o Termination of surgery due to too extensive oncological disease (open-close
surgery)
Design
Recruitment
Medical products/devices used
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 | NL78760.068.21 |