Mesh Fixation inTEP Inguinal Hernia Repair (register)

Skane University Hospital

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: Fixation of mesh in TEP

Study type: Observational

Funder types: Other

Identifiers

NCT02419950

634/2008

Details and patient eligibility

About

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.

Full description

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain.

Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain was defined as "pain present that could not be ignored". In adition a specific questionnair developed by the research group on pain and problems during sexual activiety were sent to patients between 30-60 years of age.

The register was checked for long term recurrent operations.

Enrollment: 1,110 patients

Sex: Male

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male between 30-75 years.
• Primary inguinal hernia

Exclusion criteria

• Emergency operation
• Operated for recurrence
• Deaths

Trial design

1,110 participants in 2 patient groups

No fixation of mesh in TEP

Description:

Patient having no mechanical fixation of the mesh in TEP. This will include both no fixation at all och glue fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique

Treatment:

Device: Fixation of mesh in TEP

Fixation of mesh in TEP

Description:

Patients having fixation of the mesh using mechanical, non absorbable fixating devices.This will include mechanical fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique

Treatment:

Device: Fixation of mesh in TEP