Clinical Trials Directory

Trials / Completed

CompletedNCT02419950

Mesh Fixation inTEP Inguinal Hernia Repair

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,110 (actual)
Sponsor
Skane University Hospital · Academic / Other
Sex
Male
Age
30 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEFixation of mesh in TEPAn endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation

Timeline

Start date
2008-11-01
Primary completion
2010-05-01
Completion
2013-09-01
First posted
2015-04-17
Last updated
2015-04-17

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02419950. Inclusion in this directory is not an endorsement.