Epididymo-orchitisNCT03969979
Elastography in Boys With Epididymo-orchitis
An observational study of Epididymo-orchitis, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The patients treated in our clinic for epididymoorchitis will be given scrotal shear wave elastography by the Department of Radiology and affected testis will be compared to non affected testis radiologically. Read more about this study
- Who is it for?
- Ages Up to 18 years, men only
- Conditions the study is for
- Epididymo-orchitis
- What is being tested?
- Shear wave elastography
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2019to 20 Jun 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 Up to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: The patients who had epididymo-orchitis unilaterally will be called and invited to our department for elastography. The volunteers whose legal guardians accept to be involve our study will be involved.
Who may be able to join
- To be followed-up and treated in the Department of Pediatric Surgery at Trakya University due to epidididymo-orchitis. (Inpatient and / or outpatient clinic)
- 18 years old or younger
- Approval by the legal guardian
Who cannot join
- Bilateral epididymo-orchitis
- Testicular pathology other than epididymo-orchitis (undescended testis, testicular torsion)
- Scrotal surgery (due to epididymoorchitis or not)
- Older than 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University Faculty of Medicine
Edirne, 22030
Irem Inanc, MD, +905436204929, ireminanc@trakya.edu.tr
About this study
Official title: Assesment of the Testicular Effects of Epididymo-orchitis in Boys Via Elastograpy
The patients treated in our clinic for epididymoorchitis will be given scrotal shear wave elastography by the Department of Radiology and affected testis will be compared to non affected testis radiologically. Shear wave elastography is a method of ultrasonography, which allows the focused ultrasonographic wave to be directed to the selected tissue to produce deformation of the tissue and to obtain the numerical data on the tissue elasticity by measuring the speed of the wave when the tissue is recovered. The higher the wave velocity, the lower the elasticity of the tissue.
The data to be obtained by this method will be compared statistically.
Read the detailed description
Epididymo-orchitis is an inflammatory disease of the epididymis and / or testis. The clinical picture is manifested by sudden onset testicular pain and swelling. The differential diagnosis of testicular torsion should be made in the pediatric age group. While urgent surgery is required in testicular torsion, treatment with epididymo-orchitis consists of antiinflammatory and cold application. Scrotal ultrasonography is used in the differential diagnosis and epididymo-orchitis is diagnosed in epididymis.
The scrotal ultrasound for the control after the patient's symptoms have regressed gives an idea about the course of the inflammatory process. In recent years, the introduction of elastography, which is an advanced ultrasound technique, has begun to suggest the evaluation of the elasticity of testis and epididymis in various scrotal diseases.
In epididymo-orchitis, a disease that is known with inflammation of the testicular parenchyma, a study evaluating whether there is a permanent change in the testicular parenchyma after inflammation has regressed is not yet available in the English literature. In this study, it is planned to evaluate the pediatric patients from this perspective and contribute to the literature with the results to be obtained.
- Conditions
- Epididymo-orchitis
- Being tested
- Shear wave elastography
- Keywords
- epididymo-orchitis, shear wave elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastographyDiagnostic test
shear wave elastogrophy will be performed
| Study group | Role | What they receive |
|---|---|---|
| testis with epididymo-orchitis | The patients' previously inflamed testis with epididymo-orchitis Receives: Diagnostic Test: Shear wave elastography | |
| healthy testis | The patients' non inflamed testis Receives: Diagnostic Test: Shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of post inflammation process
Shear wave elastography numbers will be analyzed statistically
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start20 Sep 2019
- Primary completion10 Jun 2020 (estimated)
- Study completion20 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epididymo-orchitisStudies 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
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Inanc, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969979
- Sponsor's protocol ID
- ccer epididimoorsit
- Status last verified
- Feb 2020
- First submitted
- 25 May 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of the Testicular Effects of Epididymo-orchitis in Boys Via Elastograpy
- ClinicalTrials.gov ID
- NCT03969979
- Acronym / sponsor ID
- ccer epididimoorsit
- Conditions
- Epididymo-orchitis
- Keywords
- epididymo-orchitis, shear wave elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 10 Jun 2020 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 31 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.
The patients treated in our clinic for epididymoorchitis will be given scrotal shear wave elastography by the Department of Radiology and affected testis will be compared to non affected testis radiologically. Shear wave elastography is a method of ultrasonography, which allows the focused ultrasonographic wave to be directed to the selected tissue to produce deformation of the tissue and to obtain the numerical data on the tissue elasticity by measuring the speed of the wave when the tissue is recovered. The higher the wave velocity, the lower the elasticity of the tissue.
The data to be obtained by this method will be compared statistically.
Detailed description
Epididymo-orchitis is an inflammatory disease of the epididymis and / or testis. The clinical picture is manifested by sudden onset testicular pain and swelling. The differential diagnosis of testicular torsion should be made in the pediatric age group. While urgent surgery is required in testicular torsion, treatment with epididymo-orchitis consists of antiinflammatory and cold application. Scrotal ultrasonography is used in the differential diagnosis and epididymo-orchitis is diagnosed in epididymis.
The scrotal ultrasound for the control after the patient's symptoms have regressed gives an idea about the course of the inflammatory process. In recent years, the introduction of elastography, which is an advanced ultrasound technique, has begun to suggest the evaluation of the elasticity of testis and epididymis in various scrotal diseases.
In epididymo-orchitis, a disease that is known with inflammation of the testicular parenchyma, a study evaluating whether there is a permanent change in the testicular parenchyma after inflammation has regressed is not yet available in the English literature. In this study, it is planned to evaluate the pediatric patients from this perspective and contribute to the literature with the results to be obtained.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testis with epididymo-orchitis | – | Diagnostic Test: Shear wave elastographyThe patients' previously inflamed testis with epididymo-orchitis |
| healthy testis | – | Diagnostic Test: Shear wave elastographyThe patients' non inflamed testis |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The patients who had epididymo-orchitis unilaterally will be called and invited to our department for elastography. The volunteers whose legal guardians accept to be involve our study will be involved.
Key inclusion criteria (3 listed)
- To be followed-up and treated in the Department of Pediatric Surgery at Trakya University due to epidididymo-orchitis. (Inpatient and / or outpatient clinic)
- 18 years old or younger
- Approval by the legal guardian
Key exclusion criteria (4 listed)
- Bilateral epididymo-orchitis
- Testicular pathology other than epididymo-orchitis (undescended testis, testicular torsion)
- Scrotal surgery (due to epididymoorchitis or not)
- Older than 18 years old
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 |
|---|---|---|
| Shear wave elastographyshear wave elastogrophy will be performed | Diagnostic test | healthy testis, testis with epididymo-orchitis |
Primary outcome
diagnosis of post inflammation process
Time frame: 3 months
Shear wave elastography numbers will be analyzed statistically
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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.
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 Epididymo-orchitis, run by Trakya University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irem Inanc, MD (+902842357641 ext. 2950, ireminanc@trakya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of post inflammation process (time frame: 3 months). 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 18 Feb 2020.