Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

NCT ID: NCT01391455

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-08-31

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.

Conditions

Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Spermatic Cord in contact with mesh

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Spermatic Cord is isolated from the 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.

Group Type: EXPERIMENTAL

Isolation of the spermatic cord from mesh

Intervention Type: PROCEDURE

The spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria

• Medically unfit for surgical repair

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chatham Kent Health Alliance

OTHER

Sponsor Role: lead

Responsible Party

Chatham Kent Health Alliance

Principal Investigators

John A Morrison, MD;FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Chatham Kent Health Alliance

Locations

Chatham Kent Health Alliance

Chatham, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

John A Morrison, MD; FRCS(C)

Role: CONTACT

hernia@johnmorrisonmd.com

519 352 0503

Facility Contacts

John A Morrison, MD;FRCS(C)

Role: primary

hernia@johnmorrisonmd.com

519 352 0503

Gary Tithecott, MD;FRCP(C)

Role: backup

gtithecott@ckha.on.ca

519 3526400

Other Identifiers

mesh isolation

Identifier Type: -

Identifier Source: org_study_id