Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair

February 16, 2017 updated by: acestari, Istituto Auxologico Italiano

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20122
        • Recruiting
        • Andrea Cestari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients affected by inguinal hernia, scheduled to undergo either open or laparoscopic extraperitoneal inguinal hernia repair

Description

Inclusion Criteria:

  • Inguinal hernia with surgical indication for surgical repair

Exclusion Criteria:

  • History of urologic surgery and/or radiotherapy
  • Recurrence of inguinal hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group Open
Patient submitted to open inguinal hernia repair
Diagnostic test: Ecocolordoppler ultrasound testicular evaluation
Ecocolordoppler ultrasound testicular evaluation
Group extraperitoneal laparoscopic
Patients submitted to total extraperitoneal laparoscopic inguinal hernia repair
Diagnostic test: Ecocolordoppler ultrasound testicular evaluation
Ecocolordoppler ultrasound testicular evaluation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2017

Primary Completion (Anticipated)

October 30, 2017

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

February 11, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAI - URO/CHIR - TEP/OPEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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