Recruiting

Observational Study

Sponsor:

Chatham Kent Health Alliance

Code:

NCT01391455

Conditions

Inguinal Hernia

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Isolation of the spermatic cord from mesh

Study Details

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.

Conditions

Inguinal Hernia

Study ID

NCT01391455

Start date

Jul, 2011

Status verified date

Jul, 2011

Completion date

Aug, 2013

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

  • Medically unfit for surgical repair

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Evaluation of groin or testicular pain lasting longer than 3 months postoperatively. [ Time Frame: 1 year postoperatively ]

Central Contacts and Locations

Central contacts

John A Morrison, MD; FRCS(C)

519 352 0503hernia@johnmorrisonmd.com

Locations

Chatham Kent Health Alliance

Recruiting

Chatham, Ontario, Canada

Contacts

John A Morrison, MD;FRCS(C)

519 352 0503hernia@johnmorrisonmd.com

Gary Tithecott, MD;FRCP(C)

519 3526400gtithecott@ckha.on.ca

Principal Investigator:

John A Morrison, MD;FRSC(C)

More Information

Sponsor

Chatham Kent Health Alliance

Last update posted

Jul 12, 2011

Last verified

Jul, 2011

Keywords

  • Inguinal hernia repair
  • Mesh
  • Groin pain
  • Testicular pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chatham Kent Health Alliance on 2011-07-12.