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NCT03056027 Clinical Trial

Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:
Evaluation of the Impact of Open or Laparoscopic Preperitoneal Inguinal Hernia Repair on Arterial and Venous Testicular Vascularization by Means of Ecocolordoppler Ultrasound Examination

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03056027
Other study ID # IAI - URO/CHIR - TEP/OPEN
Secondary ID
Status Recruiting
Phase N/A
First received February 11, 2017
Last updated February 16, 2017
Start date February 2017
Est. completion date February 28, 2018

Study information
Verified date February 2017
Source Istituto Auxologico Italiano
Contact Andrea Cestari, MD
Phone +393472710132
Email a.cestari@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Description:

Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Ecocolordoppler will evaluate:

1. testicular arterial flow (Peak Systolic Velocity Testicular Artery - End-Diastolic Velocity Testicular Artery - Resistive Index testicular Artery)

2. venous impaired outflow using varicocele classifications (DUBIN - scale 1-3; HIRSCH scale 1-5)

3. testicular volume

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date February 28, 2018
Est. primary completion date October 30, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Inguinal hernia with surgical indication for surgical repair

Exclusion Criteria:

- History of urologic surgery and/or radiotherapy

- Recurrence of inguinal hernia

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ecocolordoppler ultrasound testicular evaluation
Ecocolordoppler ultrasound testicular evaluation

Locations
Country Name City State
Italy Andrea Cestari Milano

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in arterial and venous testicular vascularization before and after inguinal hernia repair evaluation testicular of arterial and venous blood flow by means of ecocolordoppler ultrasound Preoperatively - 1 and 4 months after surgery
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