Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias
Not yet recruitingNot applicableNCT07289490
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 sati…
Study details
- Official title
- A Register-based Randomized Controlled Multicenter Trial of Laparo-endoscopic Bilateral Inguinal Hernia Repairs With an Asymptomatic Contralateral Hernia
- Conditions
- Inguinal Hernia Bilateral
- Interventions
- Procedure: Bilateral repair
- Procedure: Unilateral repair
- Sponsor
- Karolinska Institutet
- Start date
- 2026-08-18
- Primary completion
- 2031-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07289490