Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

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.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Isolation of the spermatic cord from mesh

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John A Morrison, MD; FRCS(C); Phone Number: 519 352 0503; Email: hernia@johnmorrisonmd.com

Study Locations

• Canada
  • Ontario
    • Chatham, Ontario, Canada
      • Recruiting
      • Chatham Kent Health Alliance
      • Contact: John A Morrison, MD;FRCS(C); Phone Number: 519 352 0503; Email: hernia@johnmorrisonmd.com
      • Contact: Gary Tithecott, MD;FRCP(C); Phone Number: 519 3526400; Email: gtithecott@ckha.on.ca
      • Principal Investigator: John A Morrison, MD;FRSC(C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

• Medically unfit for surgical repair

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Spermatic Cord in contact with mesh; Where the spermatic cord has been allowed to remain in contact with the mesh.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events.	1 year

Collaborators and Investigators

• Sponsor: Chatham Kent Health Alliance
• Investigators: Principal Investigator: John A Morrison, MD;FRCS(C), Chatham Kent Health Alliance

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 11, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Mesh; Groin pain; Inguinal hernia repair; Testicular pain
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: mesh isolation