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

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ClinicalTrials.gov Identifier: NCT03033381
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmet Ali Tuncer, Kocatepe University

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Change of testicular volume [ Time Frame: Change of testicular volume from preoperative to postoperative 30 days ]
    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 [ Time Frame: Change of blood flow from preoperative to postoperative 30 days ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst
Official Title  ICMJE A Comparison of Preoperative and Postoperative Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst: A Prospective Cohort Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
operated and nonoperated side testis of each patient accepted two different group.
Masking: Single (Outcomes Assessor)
Masking Description:
Statistician was masking
Primary Purpose: Diagnostic
Condition  ICMJE Inguinal Hernia Repair
Intervention  ICMJE
  • Device: Color Doppler Ultrasound
    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.
    Other Name: Operated side testis
  • Device: Color Doppler Ultrasound
    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.
    Other Name: Nonoperated side testis
Study Arms  ICMJE
  • Active Comparator: operated side testis
    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)
    Intervention: Device: Color Doppler Ultrasound
  • Sham Comparator: Contralateral testis
    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: Device: Color Doppler Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033381
Other Study ID Numbers  ICMJE 2015-KAEK-86/05-80
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmet Ali Tuncer, Kocatepe University
Study Sponsor  ICMJE Kocatepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kocatepe University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP