Surgical Complications From SurgeryPOM-MPNCT04866199
POM-MP: PeriOp Metabolic & Mitochondrial Phenotype
An observational study of Surgical Complications From Surgery and Surgical Complications From Bladder Surgery, run by Duke University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Complications From Surgery, Surgical Complications From Bladder Surgery, Surgical Complications From Bowel Surgery
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients identified in surgical clinic as candidates for bladder or bowel resection.
Who may be able to join
- 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
Who cannot join
- Unable to perform CPET
- Pregnant
- Prisoner
- Patients with diagnosed Dementia
- Unable to ambulate independently
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Surgical Complications From Surgery, Surgical Complications From Bladder Surgery, Surgical Complications From Bowel Surgery
- Keywords
- Surgery, Complication, Preoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-risk colon or bladder surgical patients | Patients who are diagnosed with colon or bladder cancer requiring surgical resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study startOct 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Why it stopped: Key investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Complications From SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B MacLeod, FRCA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866199
- Sponsor's protocol ID
- Pro00108362
- Acronym
- POM-MP
- Status last verified
- Jun 2023
- First submitted
- 27 Apr 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative Metabolic & Mitochondrial Phenotype Study: Prediction From Three Preoperative Assessments
- ClinicalTrials.gov ID
- NCT04866199
- Acronym / sponsor ID
- POM-MP / Pro00108362
- Conditions
- Surgical Complications From Surgery, Surgical Complications From Bladder Surgery, Surgical Complications From Bowel Surgery
- Keywords
- Surgery, Complication, Preoperative
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Key investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk colon or bladder surgical patients | – | –Patients who are diagnosed with colon or bladder cancer requiring surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients identified in surgical clinic as candidates for bladder or bowel resection.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Unable to perform CPET
- Pregnant
- Prisoner
- Patients with diagnosed Dementia
- Unable to ambulate independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with post-operative complications as measured by Postoperative Morbidity Survey (POMS)
Time frame: Up to 30 days post-op
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.
Change in the highest oxygen consumption (VO2 peak) as measured by wearable face mask
Time frame: Baseline (preop) and Post-op (up to 30 days)
Measured in milliliters of oxygen per min
Change in MuscleSound %iMAT as measured by portable ultrasound
Time frame: Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)
The parameter is derived using a proprietary algorithm applied to the ultrasound image to estimate the amount of intramuscular adipose tissue, presented as percentage
Change in mitochondrial oxygen consumption as measured by blood analysis
Time frame: Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)
The change between baseline and maximal oxygen consumption when maximum induced by additon of chemicals in vivo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B MacLeod, FRCA principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Complications From Surgery and Surgical Complications From Bladder Surgery, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with post-operative complications as measured by Postoperative Morbidity Survey (POMS) (time frame: Up to 30 days post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.