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Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

This study is currently recruiting participants.
Verified July 2011 by Chatham Kent Health Alliance
Sponsor:
Information provided by:
Chatham Kent Health Alliance
ClinicalTrials.gov Identifier:
NCT01391455
First received: July 6, 2011
Last updated: July 11, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    All patients will be evaluated using the Carolina's Comfort Scale


Secondary Outcome Measures:
  • Number of patients with adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

  • Medically unfit for surgical repair
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391455

Contacts
Contact: John A Morrison, MD; FRCS(C) 519 352 0503 hernia@johnmorrisonmd.com

Locations
Canada, Ontario
Chatham Kent Health Alliance Recruiting
Chatham, Ontario, Canada
Contact: John A Morrison, MD;FRCS(C)     519 352 0503     hernia@johnmorrisonmd.com    
Contact: Gary Tithecott, MD;FRCP(C)     519 3526400     gtithecott@ckha.on.ca    
Principal Investigator: John A Morrison, MD;FRSC(C)            
Sponsors and Collaborators
Chatham Kent Health Alliance
Investigators
Principal Investigator: John A Morrison, MD;FRCS(C) Chatham Kent Health Alliance
  More Information

No publications provided

Responsible Party: John A. Morrison. Chief of Surgery, Chatham Kent Health Alliance
ClinicalTrials.gov Identifier: NCT01391455     History of Changes
Other Study ID Numbers: mesh isolation
Study First Received: July 6, 2011
Last Updated: July 11, 2011
Health Authority: Chatham Kent Health Alliance Canada:

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

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

ClinicalTrials.gov processed this record on May 21, 2013