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Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?

NCT ID: NCT02203318

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

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The aim of this study is to verify whether the hypertrophy of contralateral testis may predict the absence of the non-palpable testis in the boys younger than 24months of age. According to the previous studies of other countries, the large size of the contralateral testis of the nonpalpable testis has positive correlation woth the weak viability of the affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but not normally descended testis group(group2) and control group(group3). The size of testis will be measured with Ultrasound and the length, width and the height will be measured before surgery at outpatient department. For the group 1 \& 2, the viability of the affected testis will be evaluated and compared after surgery. In addition the comparison with normal control group is also going th be conducted.

Detailed Description

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Conditions

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Focus of Study

Keywords

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cryptorchidism, undescended testis, hypertrophy of contralateral testis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

healthy children with normal bilateral testis

No interventions assigned to this group

undescended palpable testis

patient whose affected testis is not descended to the normal position but palpable and exist intact in the upper area

No interventions assigned to this group

non-paplpable testis

patient whose affected testis is not palpable during the physical examination

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. neonates or Infants who visited the out-patient clinic with nonpalpable or undescended testis.(group 1, 2) aged from 6months to 18months
2. neonates or Infants aged from 6months to 18months with normal testis (volunteers, Group3)

Exclusion Criteria

1. previous history of hormonal therapy.
2. chromosomal abnormality
3. previous history of abdomen or inguinal area surgery
4. children diagnosed with epididymitis or orchitis
5. twin baby
6. infants with premature (\<37 weeks) birth history
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0385

Identifier Type: -

Identifier Source: org_study_id