NCT03969979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

May 25, 2019

Last Update Submit

February 16, 2020

Conditions

Keywords

epididymo-orchitisshear wave elastography

Outcome Measures

Primary Outcomes (1)

  • diagnosis of post inflammation process

    Shear wave elastography numbers will be analyzed statistically

    3 months

Study Arms (2)

testis with epididymo-orchitis

The patients' previously inflamed testis with epididymo-orchitis

Diagnostic Test: Shear wave elastography

healthy testis

The patients' non inflamed testis

Diagnostic Test: Shear wave elastography

Interventions

shear wave elastogrophy will be performed

healthy testistestis with epididymo-orchitis

Eligibility Criteria

AgeUp to 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • To be followed-up and treated in the Department of Pediatric Surgery at Trakya University due to epidididymo-orchitis. (Inpatient and / or outpatient clinic)
  • years old or younger
  • Approval by the legal guardian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University Faculty of Medicine

Edirne, 22030, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Umit Nusret Basaran, Profesor, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, Trakya University Pediatric Surgery Department

Study Record Dates

First Submitted

May 25, 2019

First Posted

May 31, 2019

Study Start

September 20, 2019

Primary Completion

June 10, 2020

Study Completion

June 20, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations