Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Isolation of the spermatic cord from mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of a primary unilateral inguinal hernia Exclusion Criteria: Medically unfit for surgical repair

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Spermatic Cord in contact with mesh<br>Where the spermatic cord has been allowed to remain in contact with the mesh. | |
| Experimental: Spermatic Cord is isolated from the mesh<br>The inguinal ligament is interposed between the cord and the mesh and then repaired. This isolates the cord from the mesh and the splinting function of the overlying inguinal ligament. | Procedure: Isolation of the spermatic cord from mesh<br>* The spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of groin or testicular pain lasting longer than 3 months postoperatively. | All patients will be evaluated using the Carolina's Comfort Scale | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia repair, Mesh, Groin pain, Testicular pain