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Clinical Trial Summary

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.


Clinical Trial 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 Design


NCT number NCT04866199
Study type Observational
Source Duke University
Contact David B MacLeod, FRCA
Phone +1 919-812-3201
Email [email protected]
Status Not yet recruiting
Phase
Start date June 2021
Completion date December 2022