Not Yet RecruitingNot Applicable

Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias

Sweden2,200 participantsStarted 2026-08-18

Plain-language summary

Groin hernia repair is one of the most common surgical procedures, with around 20 million performed annually worldwide. In Sweden, over 16,000 groin hernia operations are registered each year in the Swedish Hernia Register (SHR), which has maintained 98% data completeness and validation over the past 30 years. The SHR, with currently over 400,000 recorded operations, has significantly improved the quality of hernia surgery both in Sweden and internationally. Two key outcomes that can affect a patient's quality of life after groin hernia repair are recurrence and chronic pain, both of which are tracked by the SHR and serve as quality indicators for hernia surgery in Sweden. The management of asymptomatic contralateral inguinal hernias in patients with bilateral hernias has been a topic of debate in recent decades. Most bilateral hernias are now treated laparoscopically, and this trend is growing. However, despite the prevalence of bilateral and asymptomatic contralateral hernias, there is no consensus on the optimal timing for repairing the asymptomatic side. This multicenter, register-based randomized controlled trial, using the highly validated Swedish Hernia Register, aims to investigate outcomes for asymptomatic contralateral inguinal hernias in patients with bilateral hernias.Investigate the differences in the outcome of chronic pain (patient reported outcome measure with pain questionnaire), reoperation, peri - and postoperative complications and patient satisfaction between laparo-endoscopic bilateral inguinal hernia repair with an asymptomatic contralateral groin hernia versus a laparo-endoscopic unilateral inguinal hernia repair without repairing the asymptomatic contralateral groin hernia in bilateral inguinal hernias in adults. Additionally, to study the prevalence of future elective and emergency hernia repair of the unrepaired asymptomatic contralateral inguinal hernia.The chronic pain, reoperation, peri - and postoperative complications and patient satisfaction is hypothesized to be equal between bilateral inguinal hernia repairs with an asymptomatic contralateral inguinal hernia compared to unilateral symptomatic inguinal hernia repairs

Who can participate

Age range

18 Years

Sex

ALL

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: * Elective laparo-endoscopic surgery of bilateral primary inguinal hernia * Both men and women * above and 18 years old * One of the hernias is asymptomatic * Surgical center that perform \> 50 laparo-endoscopic groin hernia repairs per year. Exclusion Criteria: * Recurrent groin hernias (earlier repair in the groin) * Femoral hernias (both symptomatic and asymptomatic) * Combined femoral groin hernias * Detected femoral hernia during surgery (they will be recommended to be operated with a bilateral repair) * Another operative procedure at the same time * A history of open lower abdominal surgery (except appendectomy) like prostate surgery * ASA fitness grade \> 3 * Patients that cannot undergo general anesthesia * Pregnancy * Age \< 18 years * Infected wounds * Emergency operation (incarcerated hernia) * Inability to fill in questionnaires due to language barriers or condition as Alzheimer's

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

Patient-reported Chronic pain 1 year after surgery via PROM

Timeframe: 1 year after surgery

Trial details

NCT IDNCT07289490

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-12-31

Contact for this trial

Maria Melkemichel, MD, PhD

+46 70 159 76 60 maria.melkemichel@ki.se

View on ClinicalTrials.gov More Inguinal Hernia Bilateral trials