Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair
Recruitment status was Recruiting
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 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|
- 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
- Number of patients with adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391455
|Contact: John A Morrison, MD; FRCS(C)||519 352 firstname.lastname@example.org|
|Chatham Kent Health Alliance||Recruiting|
|Chatham, Ontario, Canada|
|Contact: John A Morrison, MD;FRCS(C) 519 352 0503 email@example.com|
|Contact: Gary Tithecott, MD;FRCP(C) 519 3526400 firstname.lastname@example.org|
|Principal Investigator: John A Morrison, MD;FRSC(C)|
|Principal Investigator:||John A Morrison, MD;FRCS(C)||Chatham Kent Health Alliance|