Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair

NCT ID: NCT03056027

Last Updated: 2017-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2018-02-28

Brief Summary

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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

Detailed Description

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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

Conditions

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Inguinal Hernia Testicular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Open

Patient submitted to open inguinal hernia repair

Ecocolordoppler ultrasound testicular evaluation

Intervention Type DIAGNOSTIC_TEST

Ecocolordoppler ultrasound testicular evaluation

Group extraperitoneal laparoscopic

Patients submitted to total extraperitoneal laparoscopic inguinal hernia repair

Ecocolordoppler ultrasound testicular evaluation

Intervention Type DIAGNOSTIC_TEST

Ecocolordoppler ultrasound testicular evaluation

Interventions

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Ecocolordoppler ultrasound testicular evaluation

Ecocolordoppler ultrasound testicular evaluation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Inguinal hernia with surgical indication for surgical repair

Exclusion Criteria

* History of urologic surgery and/or radiotherapy
* Recurrence of inguinal hernia
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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acestari

Head Department of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Cestari, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

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Andrea Cestari

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Cestari, MD

Role: CONTACT

+393472710132

Facility Contacts

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Andrea Cestari, MD

Role: primary

+393472710132

Other Identifiers

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IAI - URO/CHIR - TEP/OPEN

Identifier Type: -

Identifier Source: org_study_id

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