Inguinal HerniaNCT03056027
Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair
An observational study of Inguinal Hernia and Testicular Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Inguinal Hernia, Testicular Diseases
- What is being tested?
- Ecocolordoppler ultrasound testicular evaluation
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2017to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by inguinal hernia, scheduled to undergo either open or laparoscopic extraperitoneal inguinal hernia repair
Who may be able to join
- Inguinal hernia with surgical indication for surgical repair
Who cannot join
- History of urologic surgery and/or radiotherapy
- Recurrence of inguinal hernia
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Andrea Cestari
Milan, 20122
Andrea Cestari, MD, +393472710132, a.cestari@auxologico.it
About this study
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
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
Read the 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:
- testicular arterial flow (Peak Systolic Velocity Testicular Artery - End-Diastolic Velocity Testicular Artery - Resistive Index testicular Artery)
- venous impaired outflow using varicocele classifications (DUBIN - scale 1-3; HIRSCH scale 1-5)
- testicular volume
- Conditions
- Inguinal Hernia, Testicular Diseases
- Being tested
- Ecocolordoppler ultrasound testicular evaluation
- Medical subject headings
- Hernia, Inguinal, Testicular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecocolordoppler ultrasound testicular evaluationDiagnostic test
Ecocolordoppler ultrasound testicular evaluation
| Study group | Role | What they receive |
|---|---|---|
| Group Open | Patient submitted to open inguinal hernia repair Receives: Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation | |
| Group extraperitoneal laparoscopic | Patients submitted to total extraperitoneal laparoscopic inguinal hernia repair Receives: Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperatively - 1 and 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startFeb 2017 (estimated)
- Primary completion30 Oct 2017 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, acestari, Istituto Auxologico Italiano
- Investigators
- Andrea Cestari, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056027
- Sponsor's protocol ID
- IAI - URO/CHIR - TEP/OPEN
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03056027
- Acronym / sponsor ID
- IAI - URO/CHIR - TEP/OPEN
- Conditions
- Inguinal Hernia, Testicular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- testicular arterial flow (Peak Systolic Velocity Testicular Artery - End-Diastolic Velocity Testicular Artery - Resistive Index testicular Artery)
- venous impaired outflow using varicocele classifications (DUBIN - scale 1-3; HIRSCH scale 1-5)
- testicular volume
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Open | – | Diagnostic Test: Ecocolordoppler ultrasound testicular evaluationPatient submitted to open inguinal hernia repair |
| Group extraperitoneal laparoscopic | – | Diagnostic Test: Ecocolordoppler ultrasound testicular evaluationPatients submitted to total extraperitoneal laparoscopic inguinal hernia repair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by inguinal hernia, scheduled to undergo either open or laparoscopic extraperitoneal inguinal hernia repair
Key inclusion criteria (1 listed)
- Inguinal hernia with surgical indication for surgical repair
Key exclusion criteria (2 listed)
- History of urologic surgery and/or radiotherapy
- Recurrence of inguinal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecocolordoppler ultrasound testicular evaluationEcocolordoppler ultrasound testicular evaluation | Diagnostic test | Group Open, Group extraperitoneal laparoscopic |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Cestari, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Testicular Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Cestari, MD (+393472710132, a.cestari@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in arterial and venous testicular vascularization before and after inguinal hernia repair (time frame: Preoperatively - 1 and 4 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.