NCT02731989

Brief Summary

In addition to the manual preoperative examination, the undescended testicle will be measured ultrasonographically. The compared data will help us to evaluate the routine need for preoperative ultrasonographic evaluation of the undescended testicle.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

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

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

April 4, 2016

Last Update Submit

July 11, 2017

Conditions

Undescended Testis

Outcome Measures

Primary Outcomes (1)

  • The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size

    The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size

    3 years

Study Arms (2)

study group

The surgeon will estimate the size difference between the undescended and the normally located testis. Independently the ultrasonographer will measure the true size of both testes in the study group.

Control group

The same measurments will be done by the surgeon and the ultrasonographer on boys without cryptorchism.

Eligibility Criteria

Age1 Year - 13 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Boys operated for unilateral cryptorchism

You may qualify if:

  • Boys operated for unilateral cryptorchism

You may not qualify if:

  • bilateral cryptorchism recurrent operation s/p inguinal operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Centre

Kfar Saba, 44281, Israel

RECRUITING

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Zvi Steiner, MD

CONTACT

050-6246788zvi.steiner@clalit.org.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

July 24, 2017

Primary Completion

July 24, 2018

Study Completion

July 24, 2019

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

IL(1)