Mesh Fixation inTEP Inguinal Hernia Repair

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: Fixation of mesh in TEP

• Registration Number: NCT02419950
• Lead Sponsor: Skane University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-05
• Study Completion: 2013-09
• Study First Submitted: 2014-09-24
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-14
• Last Update Submitted: 2015-04-14
• Study First Posted: 2015-04-17
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1110

Inclusion Criteria

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

Exclusion Criteria

• Emergency operation
• Operated for recurrence
• Deaths

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No fixation of mesh in TEP	Fixation of mesh in TEP	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
Fixation of mesh in TEP	Fixation of mesh in TEP	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

Primary Outcome Measures

Name	Time	Method
Chronic pain	5 years	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

Secondary Outcome Measures

Name	Time	Method
Sexual problems due to inguinal pain problems after hernia surgery	2-5 years	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.
A second operation for a recurrence	5-7 years	Measured as a reoperation reported in the national register

Trial Locations

Locations (1)

University of Lund,; 🇸🇪 Malmö, Sweden