Perioperative Energy Expenditure in Major Liver Resection

NCT05931068 | Recruiting DMC

• 1 other identifier: NL78760.068.21
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Liver Diseases; Liver Neoplasms

Keywords

Energy expenditure; Aerobic capacity; Resting metabolism rate; Metabolic demand; Physical activity; Pre- and post-operative assessment

Outcome Measures

Primary Outcomes (2)

• Change in energy expenditure using direct calorimetry

  Direct calorimetry applying the doubly labelled water method

  through monitoring period, average of 2 weeks perioperatively

• Change in energy expenditure using indirect calorimetry

  Indirect calorimetry applying a ventilated hood system

  through monitoring period, average of 2 weeks perioperatively

Secondary Outcomes (7)

• Preoperative aerobic fitness

  One week prior to surgery

• Postoperative aerobic fitness

  end of monitoring period, average of 2 weeks postoperatively

• Perioperative physical activity level

  through monitoring period, average of 2 weeks perioperatively

• Postoperative complications

  30-day postoperatively

• Liver-specific postoperative complications

  30-day postoperatively

Interventions

Pre- and postoperative assessment OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Netherlands

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Neoplasms; Liver Diseases; Liver Neoplasms; Motor Activity

Interventions

Lead

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Behavior

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• S.W.M. Olde Damink, MD MSc PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Hildebrand, MD

CONTACT

+31 43 388 1499; nicole.hildebrand@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: July 5, 2023
• Study Start: May 1, 2023
• Primary Completion: April 11, 2025
• Study Completion: August 31, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

NL (1)