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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 ?

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02203318
Collaborator
(none)
60
Enrollment
1
Location
11
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    May 1, 2015
    Actual Study Completion Date :
    Jun 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Size of contralateral testis [1 day of initial visit]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Months
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital, Yonsei University College of Medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02203318
    Other Study ID Numbers:
    • 4-2014-0385
    First Posted:
    Jul 29, 2014
    Last Update Posted:
    Nov 1, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Yonsei University
    cryptorchidism, undescended testis, hypertrophy of contralateral testis
    Additional relevant MeSH terms:
    Hypertrophy

    Study Results

    No Results Posted as of Nov 1, 2016