Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01391455
• Other study ID #: mesh isolation
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2011
• Last updated: July 11, 2011
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2011
• Source: Chatham Kent Health Alliance
• Contact: John A Morrison, MD; FRCS(C)
• Phone: 519 352 0503
• Email: hernia[@]johnmorrisonmd.com
• Is FDA regulated: No
• Health authority: Chatham Kent Health Alliance Canada:
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

• Medically unfit for surgical repair

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.

Locations

Country	Name	City	State
Canada	Chatham Kent Health Alliance	Chatham	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Chatham Kent Health Alliance

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of patients with adverse events.		1 year	Yes