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Patients scheduled for bladder or bowel resection will receive assessments at three time points:
At all time points the subjects will have blood samples drawn for mitochonrial function analysis and a muscle ultrasound (MuscleSound) performed. In addition, a cardiopulmonary exercise test (CPET or 'VO2 max') will be performed at the 30 day pre/post evaluation time points.
Cardiorespiratory fitness (CRF) is a measure of the efficiency to use oxygen. One method used to measure CRF is the cardiopulmonary exercise test (CPET), otherwise known as 'VO2 max'. Previous studies have shown that individuals assessed with CPET-derived parameters, such as VO2 max or anaerobic threshold (AT), below specific thresholds are at greater risk of post-operative complications, which can occur in up to 40% of surgical patients.
This study wants to determine if other methods of fitness or well-being, such as mitochondrial oxygen consumption and muscle ultrasound to determine muscle characteristics, can be combined with CPET assessment to improve the ability to identify surgical patients who develop postoperative complications, as measured by the validated tool, POMS.
The objective of the study is to create a method to identify the metabolic and mitochondrial phenotype of the perioperative patient, termed the POM-MP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk colon or bladder surgical patients | Patients who are diagnosed with colon or bladder cancer requiring surgical resection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with post-operative complications as measured by Postoperative Morbidity Survey (POMS) | Nine-domain tool used to assess the presence (or absence) of clinically significant changes using specified criteria. Confirmation of yes in any domain represents post-operative morbidity. | Up to 30 days post-op |
| Change in the highest oxygen consumption (VO2 peak) as measured by wearable face mask | Measured in milliliters of oxygen per min | Baseline (preop) and Post-op (up to 30 days) |
| Change in MuscleSound %iMAT as measured by portable ultrasound | The parameter is derived using a proprietary algorithm applied to the ultrasound image to estimate the amount of intramuscular adipose tissue, presented as percentage | Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days) |
| Change in mitochondrial oxygen consumption as measured by blood analysis | The change between baseline and maximal oxygen consumption when maximum induced by additon of chemicals in vivo | Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Surgical patients identified in surgical clinic as candidates for bladder or bowel resection.
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| Name | Affiliation | Role |
|---|---|---|
| David B MacLeod, FRCA | Duke University | Principal Investigator |
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Blood samples 30 mL taken at Baseline (preop), Postop Days 0, 1, 3 & 5 and up to Postop Day 30. Total 180 mL