CompletedNot Applicable

Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain

Sweden416 participantsStarted 2008-04

Plain-language summary

The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery. Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.

Who can participate

Age range

30 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * men between 30-75 years of age * ASA class I-II * primary unilateral inguinal hernia Exclusion Criteria: * lower midline incision below linea arcuate * large scrotal hernia * previously or current abuse,mental disease * obesity BMI \> 35 * another simultaneous operation * nonreducible hernia * severe pain in the groin without nonrelated to hernia * contraindications to general anesthesia * need of language translator * liver cirrhosis or ascites * spread cancer disease * previously irradiation in the area * lack of operations indication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).

Timeframe: One year

Trial details

NCT IDNCT00803985

SponsorSkane University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

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