Renal ColicRenal-ColicNCT05618262
Evaluation of the Emergency Imaging Strategy for the Diagnostic Management of Renal Colic
An observational study of Renal Colic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Emergency imaging is necessary for the diagnostic management of renal colic in the emergency department. Ultrasound is rapidly available and non-irradiating, allowing to look for a stone and a pyelocalic dilatation. But it is less sensitive when the stone is ureteral. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic
- How many people
- 169 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2020to 14 May 2020
- 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: Major subject (≥18 years) who was managed in the NHC emergency department from July 01, 2018 to June 30, 2019 with a final diagnosis of renal colic diagnostic
Who may be able to join
- Major subject (≥18 years)
- Subject who was managed in the NHC emergency department from July 01, 2018 to June 30, 2019 with a final diagnosis of renal colic diagnostic
- Subject who has not expressed opposition, after information, to the reuse of their data for the purpose of this research
Who cannot join
- Subject who has expressed opposition to participating in the study
- Subject under guardianship or curatorship
- Subject under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'accueil des urgences - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Emergency imaging is necessary for the diagnostic management of renal colic in the emergency department. Ultrasound is rapidly available and non-irradiating, allowing to look for a stone and a pyelocalic dilatation. But it is less sensitive when the stone is ureteral. CT has a sensitivity of 96% and a specificity of 100%. The latest French recommendations date from 2008, recommending ultrasound and an unprepared abdomen in cases of uncomplicated renal colic. For the European Society of Radiology, ultrasound should be the first-line examination. The place of a systematic CT scan as first-line examination for the diagnosis of renal colic in the emergency department is therefore still under discussion.
An evaluation of practice will make it possible to assess the imaging strategy applied in an emergency department.
- Conditions
- Renal Colic
- Keywords
- Renal Colic, Nephritic Colic, Pyelocalic dilatation
- Medical subject headings
- Renal Colic
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the practices of management of renal colic in the emergency room concerning the imaging strategy
Measured: Files analysed retrospectively from from July 01, 2018 to June 30, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start14 Jan 2020
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618262
- Sponsor's protocol ID
- 7634
- Acronym
- Renal-Colic
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Emergency Imaging Strategy for the Diagnostic Management of Renal Colic
- ClinicalTrials.gov ID
- NCT05618262
- Acronym / sponsor ID
- Renal-Colic / 7634
- Conditions
- Renal Colic
- Keywords
- Renal Colic, Nephritic Colic, Pyelocalic dilatation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 16 Nov 2022 (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.
Emergency imaging is necessary for the diagnostic management of renal colic in the emergency department. Ultrasound is rapidly available and non-irradiating, allowing to look for a stone and a pyelocalic dilatation. But it is less sensitive when the stone is ureteral. CT has a sensitivity of 96% and a specificity of 100%. The latest French recommendations date from 2008, recommending ultrasound and an unprepared abdomen in cases of uncomplicated renal colic. For the European Society of Radiology, ultrasound should be the first-line examination. The place of a systematic CT scan as first-line examination for the diagnosis of renal colic in the emergency department is therefore still under discussion.
An evaluation of practice will make it possible to assess the imaging strategy applied in an emergency department.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years) who was managed in the NHC emergency department from July 01, 2018 to June 30, 2019 with a final diagnosis of renal colic diagnostic
Key inclusion criteria (3 listed)
- Major subject (≥18 years)
- Subject who was managed in the NHC emergency department from July 01, 2018 to June 30, 2019 with a final diagnosis of renal colic diagnostic
- Subject who has not expressed opposition, after information, to the reuse of their data for the purpose of this research
Key exclusion criteria (3 listed)
- Subject who has expressed opposition to participating in the study
- Subject under guardianship or curatorship
- Subject under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of the practices of management of renal colic in the emergency room concerning the imaging strategy
Time frame: Files analysed retrospectively from from July 01, 2018 to June 30, 2019 will be examined
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 15 Dec 2023.
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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.
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 Renal Colic, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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 15 Dec 2023. 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 France. 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?
Retrospective study of the practices of management of renal colic in the emergency room concerning the imaging strategy (time frame: Files analysed retrospectively from from July 01, 2018 to June 30, 2019 will be examined). 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 15 Dec 2023.