POM-MP: PeriOp Metabolic & Mitochondrial Phenotype (POM-MP)

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

Patients scheduled for bladder or bowel resection will receive assessments at three time points:

1. Preoperatively up to 30 days prior to scheduled surgery
2. Postoperatively in hospital up to 5 days
3. 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.

Study Overview

• Status: Withdrawn
• Conditions: Surgical Complications From Surgery; Surgical Complications From Bladder Surgery; Surgical Complications From Bowel Surgery

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients identified in surgical clinic as candidates for bladder or bowel resection.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
High-risk colon or bladder surgical patients; Patients who are diagnosed with colon or bladder cancer requiring surgical resection.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: David B MacLeod, FRCA, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Preoperative; Complication
• Other Study ID Numbers: Pro00108362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No