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

NCT03033381 | Completed

• 1 other identifier: 2015-KAEK-86/05-80
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inguinal Hernia Repair

Keywords

Children; Inguinal hernia; Testis; Doppler ultrasonography

Outcome Measures

Primary Outcomes (2)

• 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 testicular volume from preoperative to postoperative 30 days

• 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.

  Change of blood flow from preoperative to postoperative 30 days

Study Arms (2)

operated side testis

ACTIVE COMPARATOR

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)

Device: Color Doppler Ultrasound

Contralateral testis

SHAM COMPARATOR

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)

Device: Color Doppler Ultrasound

Interventions

Color Doppler Ultrasound DEVICE

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.

Also known as: Operated side testis

operated side testis

Eligibility Criteria

• Age: Up to 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kocatepe University: lead

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician was masking
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Dr

Model Details: operated and nonoperated side testis of each patient accepted two different group.

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 26, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share