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Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Chatham Kent Health Alliance.
Recruitment status was:  Recruiting
Information provided by:
Chatham Kent Health Alliance Identifier:
First received: July 6, 2011
Last updated: July 11, 2011
Last verified: July 2011
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 Intervention
Inguinal Hernia Procedure: Isolation of the spermatic cord from mesh

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Chatham Kent Health Alliance:

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

Estimated Enrollment: 220
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: John A. Morrison. Chief of Surgery, Chatham Kent Health Alliance Identifier: NCT01391455     History of Changes
Other Study ID Numbers: mesh isolation
Study First Received: July 6, 2011
Last Updated: July 11, 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 processed this record on August 23, 2017