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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective laparo-endoscopic surgery of bilateral primary inguinal hernia

Both men and women

above and 18 years old

One of the hernias is asymptomatic

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bilateral repair

    Procedure/Surgery

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

  • Unilateral repair

    Procedure/Surgery

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

Treatment groups

2,200 Participants
are divided into 2 treatment groups
Group A: Bilateral repairExperimental treatment 1 intervention
Group B: Unilateral repairActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient-reported Chronic pain 1 year after surgery via PROM

To compare chronic pain 1 year after surgery between laparo-endoscopic bilateral inguinal hernia repair with an asymptomatic contralateral inguinal hernia vs a laparoscopic unilateral inguinal hernia repair without repairing the asymptomatic contralateral inguinal hernia in bilateral groin hernias in adults.This will be assessed via PROM - a questionnaire with item2 from the Inguinal Pain Questionnaire; Estimate the worst pain you felt in the operated groin during this past week. 1. No pain 2. Pain that could easily be ignored 3. Pain that could not be ignored but did not influence daily activities 4. Pain that could not be ignored, which affected concentration and performance of daily activities 5. Pain that inhibited most daily activities 6. Pain that required rest or bed rest 7. Pain so severe that you were forced to seek medical attention Chronic pain will be analysed as a binary outcome where scores on scale 1-3 = No pain and scores 4-7 = Pain

Time frame
1 year after surgery

Secondary outcomes

1

Risk of reoperation due to recurrence of the hernia repair

Risk of reoperation due to recurrence of the hernia repair between the arms

Time frame
2, 5 and 10 years after surgery
2

Perioperative complications (safety)

Perioperative complications (safety) between the arms

Time frame
Intraoperatively during surgery
3

Postoperative complications (safety)

Postoperative complications (safety) between the arms

Time frame
30 days after surgery
4

Rate of future elective hernia repair of the unrepaired asymptomatic contralateral inguinal hernia

Rate of future elective hernia repair of the unrepaired asymptomatic contralateral inguinal hernia

Time frame
1, 2, 5 and 10 years after surgery

Other outcomes

Sponsors and contacts

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