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A Comparison of Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst (IHR)

Primary Purpose

Inguinal Hernia Repair

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Color Doppler Ultrasound
Color Doppler Ultrasound
Sponsored by
Kocatepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inguinal Hernia Repair focused on measuring Children, Inguinal hernia, Testis, Doppler ultrasonography

Eligibility Criteria

undefined - 17 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Our analysis included boys who were younger than 17 years and possessing one-sided inguinal hernia, hydrocele, or cord cyst and who were otherwise healthy.

Exclusion Criteria:

  • Patients who had bilaterally inguinal hernia, hydrocele, or cord cyst

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    operated side testis

    Contralateral testis

    Arm Description

    Operated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)

    Nonoperated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)

    Outcomes

    Primary Outcome Measures

    Change of testicular volume
    Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient
    Change of blood flow
    Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    January 24, 2017
    Sponsor
    Kocatepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03033381
    Brief Title
    A Comparison of Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst
    Acronym
    IHR
    Official Title
    A Comparison of Preoperative and Postoperative Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst: A Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kocatepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Here, investigators aimed to evaluate the effect of inguinal operations performed with a modified Ferguson technique upon testicular volume and blood flow. This study involved 23 patients receiving surgery for inguinal hernia, hydrocele, and cord cyst. The color Doppler ultrasound (CDUS) was used to assess testicular volume and blood flow before and after a modified Ferguson technique surgery. The pre- and postoperative testicular volume and blood flow were compared with the contralateral testes. Statistical Package for the Social Sciences (SPSS) software was used to statistically analyze the data arising; the Mann-Whitney U test and Friedman test were used to compare samples, and P < 0.05 was accepted as statistically significant.
    Detailed Description
    Patients and Methods The study was performed prospectively with the approval of the Local Human Ethics Committee. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All patients included in the study were provided with a patient consent form. Study Group The analysis included male patients who were younger than 17 years and possessing one-sided inguinal hernia, hydrocele, or cord cyst and who were otherwise healthy. The study was performed prospectively between April 2016 and June 2016 in a medical faculty pediatric surgery unit. Study plan Following diagnosis, patients received a CDUS and testicular volume and blood flow were measured preoperatively. All patients then received surgery with modified Ferguson repair. Testicular volume and blood flow were then reassessed by CDUS on days 7 and 30 following surgery. Radiological evaluation Radiological evaluation was performed by a single radiologist using color doppler ultrasound (CDUS) preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient [1]. Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient. Statistical analysis The SPSS 15.0 (Statistical Package for the Social Sciences) software package was used for all statistical analysis. Testicular volumes and blood flow were analyzed as mean±standard deviation. The Mann-Whitney U test was used to compare differences in testicular volume and blood flow between the testis receiving surgery and the contralateral testis. Differences in preoperative, early postoperative (7 days post-surgery), and late postoperative (30 days post-surgery) testicular volume and blood flow of each testicle were compared using the Friedman test and P < 0.05 was accepted as statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia Repair
    Keywords
    Children, Inguinal hernia, Testis, Doppler ultrasonography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    operated and nonoperated side testis of each patient accepted two different group.
    Masking
    Outcomes Assessor
    Masking Description
    Statistician was masking
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    operated side testis
    Arm Type
    Active Comparator
    Arm Description
    Operated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)
    Arm Title
    Contralateral testis
    Arm Type
    Sham Comparator
    Arm Description
    Nonoperated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)
    Intervention Type
    Device
    Intervention Name(s)
    Color Doppler Ultrasound
    Other Intervention Name(s)
    Operated side testis
    Intervention Description
    Radiological evaluation was performed by a single radiologist using CDUS for operated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
    Intervention Type
    Device
    Intervention Name(s)
    Color Doppler Ultrasound
    Other Intervention Name(s)
    Nonoperated side testis
    Intervention Description
    Radiological evaluation was performed by a single radiologist using CDUS for nonoperated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
    Primary Outcome Measure Information:
    Title
    Change of testicular volume
    Description
    Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient
    Time Frame
    Change of testicular volume from preoperative to postoperative 30 days
    Title
    Change of blood flow
    Description
    Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
    Time Frame
    Change of blood flow from preoperative to postoperative 30 days

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Our analysis included boys who were younger than 17 years and possessing one-sided inguinal hernia, hydrocele, or cord cyst and who were otherwise healthy. Exclusion Criteria: Patients who had bilaterally inguinal hernia, hydrocele, or cord cyst

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Comparison of Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst

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