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

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

Conditions

• Inguinal Hernia Bilateral

Interventions

PROCEDURE

Bilateral repair

A bilateral repair is performed of both the symptomatic and the asymptomatic contralateral inguinal hernia in bilateral hernias

PROCEDURE

Unilateral repair

Unilateral repair of only the symptomatic inguinal hernia in bilateral hernias and leaving the contralateral asymptomatic inguinal hernia with no repair

Sponsors & Collaborators

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Maria Melkemichel, MD, PhD · Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet. Sweden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-18

Primary Completion

2031-12-31

Completion

2036-12-31

Countries

• Sweden

Study Locations