NCT03056027

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

February 11, 2017

Last Update Submit

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

Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation

Group extraperitoneal laparoscopic

Patients submitted to total extraperitoneal laparoscopic inguinal hernia repair

Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation

Interventions

Ecocolordoppler ultrasound testicular evaluation

Group OpenGroup extraperitoneal laparoscopic

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalTesticular Diseases

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Andrea Cestari, MD

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Cestari, MD

CONTACT

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

Locations