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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Isolation of the spermatic cord from mesh | The 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.