Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title: Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

• NCT number: NCT01391455
• Study type: Interventional
• Source: Chatham Kent Health Alliance
• Contact: John A Morrison, MD; FRCS(C)
• Phone: 519 352 0503
• Email: hernia@johnmorrisonmd.com
• Status: Recruiting
• Phase: N/A
• Start date: July 2011
• Completion date: August 2013