POM-MP: PeriOp Metabolic & Mitochondrial Phenotype

Study Overview
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Brief Summary
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Patients scheduled for bladder or bowel resection will receive assessments at three time points: Preoperatively up to 30 days prior to scheduled surgery Postoperatively in hospital up to 5 days Postoperatively up to 30 days following scheduled surgery 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.

Detailed Description
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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.

Official Title
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Peri-Operative Metabolic & Mitochondrial Phenotype Study: Prediction From Three Preoperative Assessments

Conditions
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Surgical Complications From Surgery, Surgical Complications From Bladder Surgery, Surgical Complications From Bowel Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged >18 undergoing bladder or bowel resection Able to speak English Ambulatory (assistive devices OK) Able to consent Willing to perform Cardiopulmonary Exercise Testing Exclusion Criteria: Unable to perform CPET Pregnant Prisoner Patients with diagnosed Dementia Unable to ambulate independently

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-risk colon or bladder surgical patients<br>Patients who are diagnosed with colon or bladder cancer requiring surgical resection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Complication, Preoperative