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Completed

NCT Number: NCT02419950

Mesh Fixation inTEP Inguinal Hernia Repair

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.

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Key information

Conditions

Inguinal Hernia Chronic Pain Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Lund,

Malmö, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Emergency operation
  • Operated for recurrence
  • Deaths

Treatment and study plan

Fixation of mesh in TEP

Device

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

Other names: Total Extraperitoneal Patch

Primary outcomes

  1. Chronic pain

    Time frame: 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 outcomes

  1. Sexual problems due to inguinal pain problems after hernia surgery

    Time frame: 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.

  2. A second operation for a recurrence

    Time frame: 5-7 years

    Measured as a reoperation reported in the national register

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

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

Acronym: register

Important dates

Study start
2008
Primary completion
2010
Study completion
2013
First posted
Apr 17, 2015
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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