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Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair

Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01391455
Enrollment
220
Registered
2011-07-12
Start date
2011-07-31
Completion date
2013-08-31
Last updated
2011-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal hernia repair, Mesh, Groin pain, Testicular pain

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.

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.

Interventions

PROCEDUREIsolation of the spermatic cord from mesh

The spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.

Sponsors

Chatham Kent Health Alliance
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion criteria

* Medically unfit for surgical repair

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.1 year postoperativelyAll patients will be evaluated using the Carolina's Comfort Scale

Secondary

MeasureTime frame
Number of patients with adverse events.1 year

Countries

Canada

Contacts

Primary ContactJohn A Morrison, MD; FRCS(C)
hernia@johnmorrisonmd.com519 352 0503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026