Spectrum of Epididymis and Vas Deferens Anomalies Among C... | NCT04696874

Studies
Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism

NCT04696874

Sponsor

Aswan University Hospital

Status

Completed

Last Update Posted

Jan 6, 2021Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Epididymal Cyst
Vas Deferens; Anomaly

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Dec 18, 2020

First Submission Date that Met QC Criteria

Jan 4, 2021

First Posted Date

Jan 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2021

Last Update Posted Date

Jan 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Procedure	All testes were fixed to the ipsilateral sub-dartos pouch. All epididymides and vasa deferentia were carefully examined, and any observed anomalies were recorded.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
collection of cases	retrospective from multicenter university hospital	one and half year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All included cases had photographic documentation.

Exclusion Criteria:

cases without photographic documentation.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Months

Maximum Age

125 Weeks

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah M Abdelmohsen, MD	Aswan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sarah Magdy Abdelmohsen		Cairo	P.O.Pox. 11331	Haddaek El-K	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013088	Spermatocele
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided