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临床试验/NCT05931068
NCT05931068招募中不适用

Pre- and Postoperative Energy Expenditure in Major Liver Resection: What do we Ask From a Patient?

Academisch Ziekenhuis Maastricht1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Change in energy expenditure using direct calorimetry

研究概览

简要总结

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.

详细描述

The number of major surgical procedures performed in older patients has been rising in recent years. Older-aged patients have a higher risk of postoperative morbidity and mortality. A recent Dutch study reported that 43% of the patients had a complicated postoperative course after major liver resection (≥3 segments) performed for colorectal liver metastases. The risk of postoperative complications and mortality is related to the patient's age combined with a higher prevalence of comorbidities, which both decrease the physiological reserve capacity of organ systems. As such, preoperative aerobic capacity has been found to be independently and consistently associated with postoperative outcomes after liver surgery. Interestingly, exercise prehabilitation is known to preoperatively increase the aerobic fitness of patients scheduled for major elective abdominal surgery. High-risk patients will benefit most from this, with a reduction in postoperative complications of >30%.

The conceptual hypothesis of exercise prehabilitation as part of perioperative care in patients undergoing major abdominal surgery is clear and increasingly substantiated with evidence. However, when taking into account the variation in prehabilitation programs and the variability of individual prehabilitation outcomes, there is room for improvement by exploring different rationales subserving the conceptual hypothesis of prehabilitation. One of the complementary rationales focusses on homeostasis-allostasis before and after surgery, more specifically on the preoperative metabolic 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. Insight in this can subsequently be used to further optimize the content of preoperative preventive interventions for unfit patients (exercise prehabilitation) to improve patient- and treatment-related outcomes.

Study design:

This study will be an explorative prospective observational cohort study of 18 months, in which energy expenditure will be determined pre- and postoperatively in 20 patients undergoing major elective liver resection at the Maastricht University Medical Center+ (MUMC+). Patients undergoing major liver resection (≥3 segments) were chosen for this study given the magnitude of their surgery and high prevalence of postoperative morbidity.

This is a monocenter study, where all measurements will be performed at the Clinical Research Unit of the MUMC+. Energy expenditure will be quantified one week before and one week after surgery using the doubly labelled water (DLW) technique, as well as by using indirect calorimetry measurements during the hospital admission one day before surgery, at postoperative day 1, 2, and 3, and at hospital discharge. Moreover, aerobic capacity will be determined with cardiopulmonary exercise testing (CPET) preoperatively and at hospital discharge.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in energy expenditure using direct calorimetry

时间窗: through monitoring period, average of 2 weeks perioperatively

Direct calorimetry applying the doubly labelled water method

Change in energy expenditure using indirect calorimetry

时间窗: through monitoring period, average of 2 weeks perioperatively

Indirect calorimetry applying a ventilated hood system

次要结局

  • Length of hospital stay(Through study completion, an average of 10 days)
  • Perioperative physical activity level(through monitoring period, average of 2 weeks perioperatively)
  • Postoperative complications(30-day postoperatively)
  • Liver-specific postoperative complications(30-day postoperatively)
  • Postoperative aerobic fitness(end of monitoring period, average of 2 weeks postoperatively)
  • Hospital anxiety and depression scale(Baseline (At the beginning of monitoring period))
  • Preoperative aerobic fitness(One week prior to surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Hildebrand

Coordinating Investigator

Academisch Ziekenhuis Maastricht

研究点 (1)

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