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

Focus of Study Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203318
• Other study ID #: 4-2014-0385
• Status: Completed
• Phase: N/A
• First received: July 27, 2014
• Last updated: October 31, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Months to 18 Months

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Focus of Study
• Hypertrophy

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes