Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients

NCT ID: NCT03967041

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sarcopaenia is associated with poor prognoses of in-hospital mortality in splenic abscess patients. Investigators recommend its use by surgeons in the ED to rapidly risk stratify and identify patients requiring urgent and aggressive intervention, to maximise patient outcomes and survival chances.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Splenic Abscess Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sarcopenic patients

radiological defined sarcopenia

Intervention Type DIAGNOSTIC_TEST

Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height

Non-sarcopenic patients

radiological defined sarcopenia

Intervention Type DIAGNOSTIC_TEST

Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiological defined sarcopenia

Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

106-4283C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.