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

NCT02203318 | Completed

• 1 other identifier: 4-2014-0385
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Focus of Study

Keywords

cryptorchidism, undescended testis, hypertrophy of contralateral testis

Outcome Measures

Primary Outcomes (1)

• Size of contralateral testis

  The testicular size is measured 3-dimensionally with ultrasonography. The length, width and height will be measured and the volume of testis will be evaluated.

  1 day of initial visit

Study Arms (3)

control

healthy children with normal bilateral testis

undescended palpable testis

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

non-paplpable testis

patient whose affected testis is not palpable during the physical examination

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24 children, normal control : 24 children

You may qualify if:

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

You may not qualify if:

• previous history of hormonal therapy.
• chromosomal abnormality
• previous history of abdomen or inguinal area surgery
• children diagnosed with epididymitis or orchitis
• twin baby
• infants with premature (\<37 weeks) birth history

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 27, 2014
• First Posted: July 29, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

KR (1)