Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Chatham Kent Health Alliance

Status: Unknown

Conditions: Inguinal Hernia

Treatments: Procedure: Isolation of the spermatic cord from mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT01391455

mesh isolation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion criteria

• Medically unfit for surgical repair

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Spermatic Cord in contact with mesh

No Intervention group

Description:

Where the spermatic cord has been allowed to remain in contact with the mesh.

Spermatic Cord is isolated from the mesh

Experimental group

Description:

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.

Treatment:

Procedure: Isolation of the spermatic cord from mesh