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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02419950
Acronym
register
Enrollment
1110
Registered
2015-04-17
Start date
2008-11-30
Completion date
2013-09-30
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

inguinal hernia, TEP, chronic pain, male sex, mesh fixation, quality of life, national register

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.

Interventions

DEVICEFixation of mesh in TEP

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

Sponsors

Skane University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
MALE
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Emergency operation * Operated for recurrence * Deaths

Design outcomes

Primary

MeasureTime frameDescription
Chronic pain5 yearsChronic 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

MeasureTime frameDescription
Sexual problems due to inguinal pain problems after hernia surgery2-5 yearsA 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 recurrence5-7 yearsMeasured as a reoperation reported in the national register

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026