Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

NCT01391455 | Unknown DMC

• 1 other identifier: mesh isolation
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Inguinal hernia repair; Mesh; Groin pain; Testicular pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients with adverse events.

  1 year

Study Arms (2)

Spermatic Cord in contact with mesh

NO INTERVENTION

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

Spermatic Cord is isolated from the mesh

EXPERIMENTAL

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

Interventions

Isolation of the spermatic cord from mesh PROCEDURE

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

Spermatic Cord is isolated from the mesh

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of a primary unilateral inguinal hernia

You may not qualify if:

• Medically unfit for surgical repair

Sponsors & Collaborators

• Chatham Kent Health Alliance: lead

Study Sites (1)

Chatham Kent Health Alliance

Chatham, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John A Morrison, MD;FRCS(C)

  Chatham Kent Health Alliance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John A Morrison, MD; FRCS(C)

CONTACT

519 352 0503; hernia@johnmorrisonmd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

CA (1)