FrailtyNCT04493710
Retrospective Analysis of Sarcopenia in Older Patients Undergoing Laparotomy
An observational study of Frailty and Surgery, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Assess the influence of sarcopenia on outcomes of emergency laparotomy in the over 65 age group Read more about this study
- Who is it for?
- Ages 65 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty, Surgery, Emergencies
- What is being tested?
- Sarcopenia estimation
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2015to 1 Dec 2022
- How long will I take part?
- 12 Months
- 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 65 to 110 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing emergency laparotomy aged 65 or over
Who may be able to join
- Patient aged 65 or over having emergency laparotomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
WUTH
Upton, Wirral, CH49 5PE
Conor Magee, MD, 01516785111
Greg Simpson, MB CHB
About this study
Official title: Retrospective Analysis of Sarcopenia in Older Patients Undergoing Laparotomy-
Assess the influence of sarcopenia on outcomes of emergency laparotomy in the over 65 age group
Read the detailed description
Emergency laparotomy is associated with substantial morbidity and mortality. These risks are increased in the elderly population with a third of over-80s dying within thirty days of surgery, rising to 50% at 1-year post emergency laparotomy. Many patients are frail and have multiple co-morbidities, often with coexistent malnutrition and so present a significant challenge in the emergency surgery setting. The National Emergency Laparotomy Audit has reported that greater than half of patients undergoing emergency laparotomy in the UK are over-65 years of age and are the highest risk patients with the highest mortality. This group, therefore, is one in which accurate prognostication is desirable to allow optimal treatment decisions, provision of critical care treatment, and resource allocation.
A number of multivariate risk prediction models exist including POSSUM, P-POSSUM and APACHE-II with on-going modification of P-POSSUM as part of the National Emergency Laparotomy Audit(NELA). Whilst such models are commonly used, evidence suggests that they may be less accurate in elderly patients, a group which offer difficult decision-making problems to the surgeon
. Frailty is the lack of physiological functional reserve and is commonplace in elderly patients. It has profound effects on the ability to withstand and recover from emergency surgery. Despite this, frailty does not form part of the commonly used multivariate risk prediction models.
Sarcopenia is the progressive and global loss of skeletal muscle mass as well as reduction in strength and is closely linked to frailty. Multiple methods of quantifying skeletal muscle mass and therefore sarcopenia have been defined, but calculation of psoas major cross-sectional area on pre-operative CT imaging may be the most pragmatic in the emergency setting due to routine use of pre-operative CT imaging prior to emergency laparotomy. Measurement of the psoas major as a marker of sarcopenia has been shown to predict outcomes in a wide range of surgical specialties. However, there is no consensus as to how this marker of sarcopenia should be used in surgical practice.
Proposal- To assess the utility of psoas major measurement to predict outcomes following emergency laparotomy in older patients and whether it could enhance the accuracy of mortality prediction when combined with P-POSSUM model variables.
Methods An analysis of data collected as part of the National Emergency Laparotomy Audit was conducted. Data were collected from patients over the age of 65 who underwent emergency laparotomy in Merseyside, United Kingdom between 2014 and 2018. Patients who underwent pre-operative cross-sectional imaging with abdominal CT pre-operatively were included in the analysis.
Demographic, histological, clinical, biochemical and operative data were collected and analysed by accessing patient clinical notes and electronic records.
Outcome measures included inpatient mortality, 30-day mortality and 90-day mortality.
Radiological Analysis Pre-operative CT imaging of the abdomen were accessed and analysed. Cross-sectional images at the level of the L3 inferior end plate were analysed. Cross-sectional area of the psoas major and L3 vertebral body (mm2) were calculated and a ratio of psoas major to L3 cross-sectional area calculated (PML3) . Higher PML3 values indicate higher levels of skeletal muscle mass. Cross-sectional area calculation was conducted using the area of interest tool.
Statistical Analysis Statistical analysis for continuous variables was conducted using Mann-Whitney U test and Chi-squared test for categorical variables. Receiver operating characteristics curves were used for analysis of association of PML3 with mortality.
Multivariate analysis was conducted using binary logistic regression analysis. Logistic regression models were produced including P-POSSUM variables with and without the inclusion of PML3. Receiver operating characteristic analysis of the respective logistic regression models were conducted to assess whether the addition of PML3 enhanced mortality prediction.
- Conditions
- Frailty, Surgery, Emergencies
- Being tested
- Sarcopenia estimation
- Keywords
- surgery, laparotomy, emergency, sarcopenia, frailty, mortality, risk
- Medical subject headings
- Frailty, Emergencies, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia estimationDiagnostic test
Analysis of pre-existing CT imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who die between zero and thirty days
Post-operative death
Measured: 30 days
Number of participants who die between zero and ninety days
Post-operative death
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jan 2015
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Wirral University Teaching Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor Magee, Wirral University Teaching Hospital NHS Trust
- Investigators
- Conor Magee, MD, Principal investigator, Wirral University Teaching Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493710
- Sponsor's protocol ID
- Sarco1
- Status last verified
- Oct 2020
- First submitted
- 20 Jul 2020
- Last updated
- 8 Oct 2020
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Sarcopenia in Older Patients Undergoing Laparotomy-
- ClinicalTrials.gov ID
- NCT04493710
- Acronym / sponsor ID
- Sarco1
- Conditions
- Frailty, Surgery, Emergencies
- Keywords
- surgery, laparotomy, emergency, sarcopenia, frailty, mortality, risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wirral University Teaching Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Jul 2020 (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.
Assess the influence of sarcopenia on outcomes of emergency laparotomy in the over 65 age group
Detailed description
Emergency laparotomy is associated with substantial morbidity and mortality. These risks are increased in the elderly population with a third of over-80s dying within thirty days of surgery, rising to 50% at 1-year post emergency laparotomy. Many patients are frail and have multiple co-morbidities, often with coexistent malnutrition and so present a significant challenge in the emergency surgery setting. The National Emergency Laparotomy Audit has reported that greater than half of patients undergoing emergency laparotomy in the UK are over-65 years of age and are the highest risk patients with the highest mortality. This group, therefore, is one in which accurate prognostication is desirable to allow optimal treatment decisions, provision of critical care treatment, and resource allocation.
A number of multivariate risk prediction models exist including POSSUM, P-POSSUM and APACHE-II with on-going modification of P-POSSUM as part of the National Emergency Laparotomy Audit(NELA). Whilst such models are commonly used, evidence suggests that they may be less accurate in elderly patients, a group which offer difficult decision-making problems to the surgeon
. Frailty is the lack of physiological functional reserve and is commonplace in elderly patients. It has profound effects on the ability to withstand and recover from emergency surgery. Despite this, frailty does not form part of the commonly used multivariate risk prediction models.
Sarcopenia is the progressive and global loss of skeletal muscle mass as well as reduction in strength and is closely linked to frailty. Multiple methods of quantifying skeletal muscle mass and therefore sarcopenia have been defined, but calculation of psoas major cross-sectional area on pre-operative CT imaging may be the most pragmatic in the emergency setting due to routine use of pre-operative CT imaging prior to emergency laparotomy. Measurement of the psoas major as a marker of sarcopenia has been shown to predict outcomes in a wide range of surgical specialties. However, there is no consensus as to how this marker of sarcopenia should be used in surgical practice.
Proposal- To assess the utility of psoas major measurement to predict outcomes following emergency laparotomy in older patients and whether it could enhance the accuracy of mortality prediction when combined with P-POSSUM model variables.
Methods An analysis of data collected as part of the National Emergency Laparotomy Audit was conducted. Data were collected from patients over the age of 65 who underwent emergency laparotomy in Merseyside, United Kingdom between 2014 and 2018. Patients who underwent pre-operative cross-sectional imaging with abdominal CT pre-operatively were included in the analysis.
Demographic, histological, clinical, biochemical and operative data were collected and analysed by accessing patient clinical notes and electronic records.
Outcome measures included inpatient mortality, 30-day mortality and 90-day mortality.
Radiological Analysis Pre-operative CT imaging of the abdomen were accessed and analysed. Cross-sectional images at the level of the L3 inferior end plate were analysed. Cross-sectional area of the psoas major and L3 vertebral body (mm2) were calculated and a ratio of psoas major to L3 cross-sectional area calculated (PML3) . Higher PML3 values indicate higher levels of skeletal muscle mass. Cross-sectional area calculation was conducted using the area of interest tool.
Statistical Analysis Statistical analysis for continuous variables was conducted using Mann-Whitney U test and Chi-squared test for categorical variables. Receiver operating characteristics curves were used for analysis of association of PML3 with mortality.
Multivariate analysis was conducted using binary logistic regression analysis. Logistic regression models were produced including P-POSSUM variables with and without the inclusion of PML3. Receiver operating characteristic analysis of the respective logistic regression models were conducted to assess whether the addition of PML3 enhanced mortality prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing emergency laparotomy aged 65 or over
Key inclusion criteria (1 listed)
- Patient aged 65 or over having emergency laparotomy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcopenia estimationAnalysis of pre-existing CT imaging | Diagnostic test | – |
Primary outcome
Number of participants who die between zero and thirty days
Time frame: 30 days
Post-operative death
Number of participants who die between zero and ninety days
Time frame: 90 days
Post-operative death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
Conor Magee, MD principal investigator
Wirral University Teaching Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Surgery, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conor Magee, MD (+441516785111, conormagee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who die between zero and thirty days (time frame: 30 days). The study lists 2 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 8 Oct 2020.