Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Procedure: Isolation of the spermatic cord from mesh

• Registration Number: NCT01391455
• Lead Sponsor: Chatham Kent Health Alliance

Brief 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.

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-11
• Last Update Submitted: 2011-07-11
• Study First Posted: 2011-07-12
• Last Update Posted: 2011-07-12
• Primary Completion: 2012-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 220

Inclusion Criteria

• Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria

• Medically unfit for surgical repair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spermatic Cord is isolated from the mesh	Isolation of the spermatic cord from mesh	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.	1 year postoperatively	All patients will be evaluated using the Carolina's Comfort Scale

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events.	1 year

Trial Locations

Locations (1)

Chatham Kent Health Alliance; 🇨🇦 Chatham, Ontario, Canada