Mesh Fixation inTEP Inguinal Hernia Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Mesh Fixation on Chronic Pain in Total Extraperitoneal (TEP) Inguinal Hernia Repair - a National Register Based Study

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: Fixation of mesh in TEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male between 30-75 years. Primary inguinal hernia Exclusion Criteria: Emergency operation Operated for recurrence Deaths

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No fixation of mesh in TEP<br>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 | Device: Fixation of mesh in TEP<br>* An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation<br>* Other names: Total Extraperitoneal Patch;|
| Fixation of mesh in TEP<br>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 | Device: Fixation of mesh in TEP<br>* An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation<br>* Other names: Total Extraperitoneal Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain | Chronic pain is meassured using an Enquirer sent to the patients by mail containing general questions to be able to exclude patients having a chronic pain problem due to other causes than the hernia (like back pain and other operations in the area) SF 36 questionnair for global measures of physical and mental Health and an validated inguinal hernia specific questionnaire for measuring pain, IPQ (Inguinal Pain Questionnair) was used | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual problems due to inguinal pain problems after hernia surgery | A specific questionnair, localy developed, for deltaled information on type, frequency, duration,intensety, disabeling and location of pain together with questions on interferance with errection, ejacculation as well as interferance with general well beeing. | 2-5 years | 
| A second operation for a recurrence | Measured as a reoperation reported in the national register | 5-7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, TEP, chronic pain, male sex, mesh fixation, quality of life, national register