Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01391455
Recruitment Status : Unknown
Verified July 2011 by Chatham Kent Health Alliance.
Recruitment status was:  Recruiting
First Posted : July 12, 2011
Last Update Posted : July 12, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Isolation of the spermatic cord from mesh Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair
Study Start Date : July 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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.

Primary Outcome Measures :
  1. Evaluation of groin or testicular pain lasting longer than 3 months postoperatively. [ Time Frame: 1 year postoperatively ]
    All patients will be evaluated using the Carolina's Comfort Scale

Secondary Outcome Measures :
  1. Number of patients with adverse events. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

  • Medically unfit for surgical repair

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01391455

Contact: John A Morrison, MD; FRCS(C) 519 352 0503

Canada, Ontario
Chatham Kent Health Alliance Recruiting
Chatham, Ontario, Canada
Contact: John A Morrison, MD;FRCS(C)    519 352 0503   
Contact: Gary Tithecott, MD;FRCP(C)    519 3526400   
Principal Investigator: John A Morrison, MD;FRSC(C)         
Sponsors and Collaborators
Chatham Kent Health Alliance
Principal Investigator: John A Morrison, MD;FRCS(C) Chatham Kent Health Alliance

Responsible Party: John A. Morrison. Chief of Surgery, Chatham Kent Health Alliance Identifier: NCT01391455     History of Changes
Other Study ID Numbers: mesh isolation
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Chatham Kent Health Alliance:
Inguinal hernia repair
Groin pain
Testicular pain

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal