- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967041
Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients
Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients- A Retrospective Case Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Splenic abscess is a life-threatening surgical emergency which requires early diagnosis and intervention to maximise patient outcomes. This can be achieved through accurate risk stratification in the emergency department (ED). Sarcopaenia refers to an age-related loss of skeletal muscle mass and strength with major physiologic and clinical ramifications. This study evaluates sarcopaenia as a radiological risk stratification tool to predict in-hospital mortality of splenic abscess patients.
99 adult patients at four training and research hospitals who had undergone abdominal contrast CT scans in the ED with the final diagnosis of splenic abscess from January 2005 to December 2015 were recruited. Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height. Univariate analyses were used to evaluate the differences between survivors and non-survivors, with subsequent logistic regression analysis to assess odds ratio of sarcopaenia with respect to in-hospital mortality. A receiver operating characteristic (ROC) curve was plotted to determine predictability of sarcopaenia, with its corresponding sensitivity, specificity, and accuracy rate calculated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All adult patients older than 20 years of age admitted to the aforementioned hospitals who had undergone an abdominal contrast CT scan in the ED with the final diagnosis of splenic abscess from January 2005 to December 2015
Exclusion Criteria:
Patients who could not be assessed for sarcopaenia in line with our study methodology and/or had other coexisting infections were excluded. Patients with abscesses involving the psoas muscles were also excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sarcopenic patients
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Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height
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Non-sarcopenic patients
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Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Up to 12 weeks
|
In-hospital mortality during hospitalization
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Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106-4283C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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