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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Conor Magee, MD contact

+441516785111

conormagee@nhs.net

United Kingdom1 site, 1 recruiting
  • WUTH

    Upton, Wirral, CH49 5PE

    Conor Magee, MD, 01516785111

    Greg Simpson, MB CHB

    Recruiting

Other trials in United Kingdom

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.

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.

  1. Number of participants who die between zero and thirty days

    Post-operative death

    Measured: 30 days

  2. 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.

  1. First posted30 Jul 2020
  2. Study start1 Jan 2015
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

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
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

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.

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