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Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056027
Recruitment Status : Unknown
Verified February 2017 by acestari, Istituto Auxologico Italiano.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
acestari, Istituto Auxologico Italiano

Study Description
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Brief 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

Condition or disease Intervention/treatment
Inguinal Hernia Testicular Diseases Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Ultrasound

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by inguinal hernia, scheduled to undergo either open or laparoscopic extraperitoneal inguinal hernia repair
Criteria

Inclusion Criteria:

  • Inguinal hernia with surgical indication for surgical repair

Exclusion Criteria:

  • History of urologic surgery and/or radiotherapy
  • Recurrence of inguinal hernia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056027


Contacts
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Contact: Andrea Cestari, MD +393472710132 a.cestari@auxologico.it

Locations
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Italy
Andrea Cestari Recruiting
Milano, Italy, 20122
Contact: Andrea Cestari, MD    +393472710132    a.cestari@auxologico.it   
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Andrea Cestari, MD Istituto Auxologico Italiano
More Information
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Responsible Party: acestari, Head Department of Urology, Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT03056027    
Other Study ID Numbers: IAI - URO/CHIR - TEP/OPEN
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Testicular Diseases
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
 Hernia, Abdominal
Gonadal Disorders
Endocrine System Diseases