Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair
Evaluation of the Impact of Open or Laparoscopic Preperitoneal Inguinal Hernia Repair on Arterial and Venous Testicular Vascularization by Means of Ecocolordoppler Ultrasound Examination
1 other identifier
observational
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 11, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedFebruary 17, 2017
February 1, 2017
9 months
February 11, 2017
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group Open
Patient submitted to open inguinal hernia repair
Group extraperitoneal laparoscopic
Patients submitted to total extraperitoneal laparoscopic inguinal hernia repair
Interventions
Ecocolordoppler ultrasound testicular evaluation
Eligibility Criteria
Patients affected by inguinal hernia, scheduled to undergo either open or laparoscopic extraperitoneal inguinal hernia repair
You may qualify if:
- Inguinal hernia with surgical indication for surgical repair
You may not qualify if:
- History of urologic surgery and/or radiotherapy
- Recurrence of inguinal hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrea Cestari
Milan, 20122, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Cestari, MD
Istituto Auxologico Italiano
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Department of Urology
Study Record Dates
First Submitted
February 11, 2017
First Posted
February 16, 2017
Study Start
February 1, 2017
Primary Completion
October 30, 2017
Study Completion
February 28, 2018
Last Updated
February 17, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share