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

NCT07289490 | Not Yet Recruiting

• 1 other identifier: BILAP HERNIA TRIAL
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bilateral inguinal hernia; chronic pain; recurrence; asymptomatic contralateral inguinal hernia

Outcome Measures

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

  1 year after surgery

Secondary Outcomes (8)

• Risk of reoperation due to recurrence of the hernia repair

  2, 5 and 10 years after surgery

• Perioperative complications (safety)

  Intraoperatively during surgery

• Postoperative complications (safety)

  30 days after surgery

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

  1, 2, 5 and 10 years after surgery

• Rate of future emergency hernia repair of the unrepaired asymptomatic contralateral inguinal hernia

  within 2 years after surgery

Study Arms (2)

Bilateral repair

EXPERIMENTAL

Bilateral repair of both the symptomatic and the contralateral asymptomatic inguinal hernia in bilateral hernias

Procedure: Bilateral repair

Unilateral repair

ACTIVE COMPARATOR

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

Procedure: Unilateral repair

Interventions

Bilateral repair PROCEDURE

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

Bilateral repair

Unilateral repair PROCEDURE

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

Unilateral repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet. Sweden

Stockholm, Sweden

Location

MeSH Terms

Conditions

Chronic Pain; Recurrence

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Maria Melkemichel, MD, PhD

  Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet. Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Melkemichel, MD, PhD

CONTACT

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

Hanna de la Croix, MD, PhD, Associate professor

CONTACT

+46 70 516 57 84; hanna.nilsson@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, General surgeon, Karolinska University Hospital, Sweden

Model Details: Register-based randomized controlled trial between 2 parallel arm groups

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 17, 2025
• Study Start (Estimated): August 18, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2036
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)