Splenic AbscessNCT03967041
Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients
An observational study of Splenic Abscess and Sarcopenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Splenic Abscess, Sarcopenia
- What is being tested?
- radiological defined sarcopenia
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 15 Apr 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients visited emergency department with the diagnosis of splenic abscess
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients- A Retrospective Case Control Study
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.
Read the 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.
- Conditions
- Splenic Abscess, Sarcopenia
- Being tested
- radiological defined sarcopenia
- Keywords
- splenic abscess, sarcopenia, surgical emergency
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiological defined sarcopeniaDiagnostic test
Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic patients | Not described Receives: Diagnostic Test: radiological defined sarcopenia | |
| Non-sarcopenic patients | Not described Receives: Diagnostic Test: radiological defined sarcopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality during hospitalization
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jan 2019
- Primary completion30 Mar 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenic AbscessStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967041
- Sponsor's protocol ID
- 106-4283C
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopaenia is a Useful Risk Stratification Tool for Surgeons to Prognosticate Splenic Abscess Patients- A Retrospective Case Control Study
- ClinicalTrials.gov ID
- NCT03967041
- Acronym / sponsor ID
- 106-4283C
- Conditions
- Splenic Abscess, Sarcopenia
- Keywords
- splenic abscess, sarcopenia, surgical emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 30 May 2019 (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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic patients | – | Diagnostic Test: radiological defined sarcopenia |
| Non-sarcopenic patients | – | Diagnostic Test: radiological defined sarcopenia |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients visited emergency department with the diagnosis of splenic abscess
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| radiological defined sarcopeniaEvaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height | Diagnostic test | Non-sarcopenic patients, Sarcopenic patients |
Primary outcome
Mortality
Time frame: Up to 12 weeks
In-hospital mortality during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Splenic Abscess and Sarcopenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 30 May 2019. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: Up to 12 weeks). 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 30 May 2019.