Urinary CalculiNCT02983409
Analysis the Relationship Between the Abdomen CT and Outcomes in Acute Urinary Stone Patients
An observational study of Urinary Calculi and Emergency Service, Hospital, run by Konkuk University Medical Center.
Trial summary
This is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. Aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Calculi, Emergency Service, Hospital
- What is being tested?
- Pstone
- Type of treatment
- Surgery or procedure
- How many people
- 862 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A adult (>18 years) patients who was diagnosed as ureter stone. They had no previous history of ureter stone within recent 1 year. They should not have a uninary congenital or acquired anomaly and chronic renal disease.
Who may be able to join
- ED Patients
- Age > 18 years
- Confirmed the ureter stone by Abdomen or Urinary CT
Who cannot join
- Known a uninary congenital or acquired anomaly
- combined other healthy preblem at the ED
- infection, renal dysfunction et al
- Known the chronic disease : Hypertension ,Diabetes, Tuberculosis, Malignance et al
About this study
Official title: A Study of Analysis the Relationship Between the Findings of Abdominal Comptuted Tomography and the Clinical Outcomes in Acute Urinary Stone Patients
This is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. Aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ED).
Read the detailed description
Gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a ureter stone patient.There was no known well of efficacy of CT for predicting the outcomes in ureter stone patient in ED.
Hypothesis of this study are some findings of non-contrast CT may be helpful to predict the clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ED within 5 days after discharge. Investigators analyzed multiple variables including age, sex, initial clinical findings, and various CT findings to assess their association with outcomes; multidose of painkiller in ED, admission at ED and revisit to ED within 5 days.
- Conditions
- Urinary Calculi, Emergency Service, Hospital
- Being tested
- Pstone
- Keywords
- computerized tomography, Urinary Calculi, Patient admission, Pain
- Medical subject headings
- Urinary Calculi, Emergencies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PstoneRadiation
A adult patients who were diagnosed as urinary stone by the urinary CT
| Study group | Role | What they receive |
|---|---|---|
| Pstone | Adult Patients (> 18years) who were diagnosed as the urinary stone in the ED. All patients who visited the ED with compalin of acute pain, and urinary stone was idenfied by urinary CT in the ED. Receives: Radiation: Pstone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple-painkiller
Patient who take the over 2 painkiller medication because of serious pain.
Measured: within 6 hours after the ED visit
Admission at ED
Patient who admitted at the ED
Measured: within 24 hours after the ED visit
Revisit to the hospital within 5 days
Patient who revisit the hospital within 5 days after the ED discharge
Measured: within 5 days after the ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang O, Park, Konkuk University Medical Center
- Investigators
- Sang O Park, Dr, Principal investigator, 1Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983409
- Sponsor's protocol ID
- UstoneCT
- Status last verified
- Aug 2017
- First submitted
- 26 Oct 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Analysis the Relationship Between the Findings of Abdominal Comptuted Tomography and the Clinical Outcomes in Acute Urinary Stone Patients
- ClinicalTrials.gov ID
- NCT02983409
- Acronym / sponsor ID
- UstoneCT
- Conditions
- Urinary Calculi, Emergency Service, Hospital
- Keywords
- computerized tomography, Urinary Calculi, Patient admission, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
This is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. Aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ED).
Detailed description
Gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a ureter stone patient.There was no known well of efficacy of CT for predicting the outcomes in ureter stone patient in ED.
Hypothesis of this study are some findings of non-contrast CT may be helpful to predict the clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ED within 5 days after discharge. Investigators analyzed multiple variables including age, sex, initial clinical findings, and various CT findings to assess their association with outcomes; multidose of painkiller in ED, admission at ED and revisit to ED within 5 days.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pstone | – | Radiation: PstoneAdult Patients (> 18years) who were diagnosed as the urinary stone in the ED. All patients who visited the ED with compalin of acute pain, and urinary stone was idenfied by urinary CT in the ED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A adult (>18 years) patients who was diagnosed as ureter stone. They had no previous history of ureter stone within recent 1 year. They should not have a uninary congenital or acquired anomaly and chronic renal disease.
Key inclusion criteria (3 listed)
- ED Patients
- Age > 18 years
- Confirmed the ureter stone by Abdomen or Urinary CT
Key exclusion criteria (4 listed)
- Known a uninary congenital or acquired anomaly
- combined other healthy preblem at the ED
- Known the chronic disease : Hypertension ,Diabetes, Tuberculosis, Malignance et al
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 |
|---|---|---|
| PstoneA adult patients who were diagnosed as urinary stone by the urinary CT | Radiation | Pstone |
Primary outcome
Multiple-painkiller
Time frame: within 6 hours after the ED visit
Patient who take the over 2 painkiller medication because of serious pain.
Admission at ED
Time frame: within 24 hours after the ED visit
Patient who admitted at the ED
Revisit to the hospital within 5 days
Time frame: within 5 days after the ED discharge
Patient who revisit the hospital within 5 days after the ED discharge
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 22 Aug 2017.
- 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.
Sang O Park, Dr principal investigator
1Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Calculi and Emergency Service, Hospital, run by Konkuk University Medical Center.
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 3 inclusion and 4 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Multiple-painkiller (time frame: within 6 hours after the ED visit). The study lists 3 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 22 Aug 2017.