Perioperative Energy Expenditure in Major Liver Resection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Ziekenhuis Maastricht

About this trial

Rationale: 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 programs that might improve postoperative outcomes.

Objective: This study aims to explore the difference of pre- and postoperative energy expenditure in patients undergoing major elective liver resection and relate this to their preoperative aerobic capacity.

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.

Study population: Patients aged ≥18 years undergoing major liver resection (≥3 segments) will be asked to participate. The inability to perform cardiopulmonary exercise testing, neo-adjuvant chemotherapy, and cirrhotic liver are reasons for exclusion.

Main study parameters/endpoints: The main study parameter is the difference of energy expenditure pre- and postoperatively, as measured with doubly labelled water and indirect calorimetry.

Secondary endpoints: Additionally, as secondary endpoints, aerobic fitness, physical activity level, and postoperative complications will be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Scheduled for open liver resection (≥3 segments) at the MUMC+

Able to understand the Dutch language sufficiently to give consent and follow orders during study assessments

Disqualifiers

Cirrhotic liver

Unable or unwilling to perform CPET or indirect calorimetry

Liver ablation as the primary treatment

Termination of surgery due to too extensive oncological disease (open-close surgery

Trial population

adults, requiring major liver resection (≥3 segments) for any kind of malignant indication at Maastricht UMC+

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pre- and postoperative assessment

    Other intervention

    Pre- and postoperative assessment will consist of measurement of energy expenditure (direct and indirect calorimetry), aerobic capacity (cardiopulmonary exercise test), and physical activity (accelerometry).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in energy expenditure using direct calorimetry

Direct calorimetry applying the doubly labelled water method

Time frame
through monitoring period, average of 2 weeks perioperatively
2

Change in energy expenditure using indirect calorimetry

Indirect calorimetry applying a ventilated hood system

Time frame
through monitoring period, average of 2 weeks perioperatively

Secondary outcomes

1

Preoperative aerobic fitness

Estimation of aerobic fitness using the gold standard of cardiopulmonary exercise testing, expressed as the maximal oxygen uptake (VO2) at the ventilatory anaerobic threshold

Time frame
One week prior to surgery
2

Postoperative aerobic fitness

Estimation of aerobic fitness using the gold standard of cardiopulmonary exercise testing, expressed as the maximal oxygen uptake (VO2) at the ventilatory anaerobic threshold

Time frame
end of monitoring period, average of 2 weeks postoperatively
3

Perioperative physical activity level

Accelerometry data of tri-axial movement

Time frame
through monitoring period, average of 2 weeks perioperatively
4

Postoperative complications

Postoperative complications rated according to Clavien-Dindo classification

Time frame
30-day postoperatively

Other outcomes

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