CompletedNot Applicable

Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

Sweden384 participantsStarted 2006-04

Plain-language summary

The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.

Who can participate

Age range

20 Years – 80 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: * Unilateral inguinal hernia * suitable for open mesh repair in local anesthesia as well as laparoscopic repair * ASA score I-III * informed consent Exclusion Criteria: * ASA score IV (not suitable for TEP) * bilateral hernias (laparoscopic repair preferable) * recurrent hernia (primary repair affects preferable treatment) * large scrotal hernias (not suitable for local anesthesia) * earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)

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

long-term post operative pain

Timeframe: 6 wks, 1 year

Trial details

NCT IDNCT01020058

SponsorUppsala University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Hernia, Inguinal trials