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
| Type | Name | Description |
|---|---|---|
| DEVICE | Fixation 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 |
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.