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

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

Tracking Information

• First Submitted Date: January 5, 2017
• First Posted Date: January 26, 2017
• Last Update Posted Date: January 26, 2017
• Study Start Date: April 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparison of Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst
• 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Inguinal Hernia Repair

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2017): 23
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: up to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03033381
• Other Study ID Numbers: 2015-KAEK-86/05-80
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ahmet Ali Tuncer, Kocatepe University
• Original Responsible Party: Same as current
• Current Study Sponsor: Kocatepe University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kocatepe University
• Verification Date: January 2017