Epididymal CystNCT04696874
Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism
An observational study of Epididymal Cyst and Vas Deferens; Anomaly, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where… Read more about this study
- Who is it for?
- Ages 8 months to 125 weeks, men only
- Conditions the study is for
- Epididymal Cyst, Vas Deferens; Anomaly
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 28 Feb 2019
- How long will I take part?
- 1 Year
- 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 8 months to 125 weeks
- Men only
- Child
Study population: We retrospectively collected data from patients with anomalies of the epididymis or vas deferens. These anomalies were discovered incidentally during operative intervention for cryptorchidism
Who may be able to join
- All included cases had photographic documentation.
Who cannot join
- cases without photographic documentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism: A Retrospective Multi-center Study
: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.
Read the detailed description
Background: Epididymal and vas deferens anomalies are not rare among children with cryptorchidism. They may affect fertility following orchiopexy.
Material and Methods: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.
- Conditions
- Epididymal Cyst, Vas Deferens; Anomaly
- Keywords
- epididymal cyst, duplicated vas deferens., curled vas deferens, vanished testis
- Medical subject headings
- Spermatocele, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure or surgery
All testes were fixed to the ipsilateral sub-dartos pouch. All epididymides and vasa deferentia were carefully examined, and any observed anomalies were recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
collection of cases
retrospective from multicenter university hospital
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Sep 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epididymal CystStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy, Aswan University Hospital
- Investigators
- Sarah M Abdelmohsen, MD, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696874
- Sponsor's protocol ID
- AswanUH1
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism: A Retrospective Multi-center Study
- ClinicalTrials.gov ID
- NCT04696874
- Acronym / sponsor ID
- AswanUH1
- Conditions
- Epididymal Cyst, Vas Deferens; Anomaly
- Keywords
- epididymal cyst, duplicated vas deferens., curled vas deferens, vanished testis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 6 Jan 2021 (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.
: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.
Detailed description
Background: Epididymal and vas deferens anomalies are not rare among children with cryptorchidism. They may affect fertility following orchiopexy.
Material and Methods: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 8 months to 125 weeks
- Sex
- Male only
- Age groups
- Child
- Study population
- We retrospectively collected data from patients with anomalies of the epididymis or vas deferens. These anomalies were discovered incidentally during operative intervention for cryptorchidism
Key inclusion criteria (1 listed)
- All included cases had photographic documentation.
Key exclusion criteria (1 listed)
- cases without photographic documentation.
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 |
|---|---|---|
| All testes were fixed to the ipsilateral sub-dartos pouch. All epididymides and vasa deferentia were carefully examined, and any observed anomalies were recorded. | Procedure or surgery | – |
Primary outcome
collection of cases
Time frame: one and half year
retrospective from multicenter university hospital
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 6 Jan 2021.
- Individual participant dataSharing planned: Undecided
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.
Sarah M Abdelmohsen, MD principal investigator
Aswan University
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 Epididymal Cyst and Vas Deferens; Anomaly, run by Aswan University Hospital at 1 site in Egypt.
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 1 inclusion and 1 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 6 Jan 2021. 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 Egypt. 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?
collection of cases (time frame: one and half year). 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 6 Jan 2021.