Clinical Trials Directory

Trials / Unknown

UnknownNCT01391455

Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
220 (estimated)
Sponsor
Chatham Kent Health Alliance · Academic / Other
Sex
Male
Age
21 Years
Healthy volunteers
Not accepted

Summary

There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.

Detailed description

In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.

Conditions

Interventions

TypeNameDescription
PROCEDUREIsolation of the spermatic cord from meshThe spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.

Timeline

Start date
2011-07-01
Primary completion
2012-08-01
Completion
2013-08-01
First posted
2011-07-12
Last updated
2011-07-12

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01391455. Inclusion in this directory is not an endorsement.