Elastography in Boys With Epididymo-orchitis

Sponsor
Trakya University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03969979
Collaborator
(none)
45
1
9
5

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Shear wave elastography

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

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Assesment of the Testicular Effects of Epididymo-orchitis in Boys Via Elastograpy
Actual Study Start Date :
Sep 20, 2019
Anticipated Primary Completion Date :
Jun 10, 2020
Anticipated Study Completion Date :
Jun 20, 2020

Arms and Interventions

Arm Intervention/Treatment
testis with epididymo-orchitis

The patients' previously inflamed testis with epididymo-orchitis

Diagnostic Test: Shear wave elastography
shear wave elastogrophy will be performed

healthy testis

The patients' non inflamed testis

Diagnostic Test: Shear wave elastography
shear wave elastogrophy will be performed

Outcome Measures

Primary Outcome Measures

  1. diagnosis of post inflammation process [3 months]

    Shear wave elastography numbers will be analyzed statistically

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Trakya University Faculty of Medicine Edirne Turkey 22030

Sponsors and Collaborators

  • Trakya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Irem Inanc, Resident Doctor, Trakya University Pediatric Surgery Department, Trakya University
ClinicalTrials.gov Identifier:
NCT03969979
Other Study ID Numbers:
  • ccer epididimoorsit
First Posted:
May 31, 2019
Last Update Posted:
Feb 18, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Irem Inanc, Resident Doctor, Trakya University Pediatric Surgery Department, Trakya University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2020