Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT07461558
- Status
- Recruiting
Conditions
- Inguinal Hernia Bilateral
- Inguinal Hernia Unilateral
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines — PROCEDUREPatients in the immediate occult hernia repair arm will under TAPP repair with placement of mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.
- Watchful waiting with supportive care — PROCEDUREPatients in the watchful waiting group will undergo standard TAPP inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone. These patients will be followed postoperatively for occult hernia related emergencies including incarceration, strangulation or obstruction.
Study Details
This study will compare two ways of managing a small, hidden hernia that can sometimes be found during minimally invasive surgery to repair a hernia on one side of the groin. Occasionally while fixing the known hernia, the surgeon discovers a small hernia on the other side that has not caused any symptoms. Surgeons do not agree on the best way to handle these hernias. Some believe it should be repaired right away during the same operation to prevent it from getting bigger or from causing symptoms later, which could require another surgery. Others believe it is better to leave it alone since it is not causing problems and groin hernia surgery carries risks including long-term pain. This study will randomly assign patients, if a hidden hernia is found during surgery, to either having it repaired immediately or to have it monitored over time. Patients will be followed up at 30 days, 1 year and 2 years following surgery. The researchers will compare recovery and quality of life between the two groups. For those in the monitoring group, the study will also track whether the hidden hernia causes symptoms or eventually needs surgery. The goal is to determine whether repairing the hidden hernia right away is as safe and effective as watching and waiting, so doctors and patients can make more informed decisions in the future.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 380 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Immediate occult hernia repair groupPatients who are randomized to immediate occult hernia repair will undergo TAPP hernia repair with mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.
- Active Comparator: Watchful waiting occult hernia groupPatients randomized to the watchful waiting group will undergo standard transabdominal preperitoneal inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone.
Primary Outcome Measure
30-day (±15) post-operative quality of life [ Time Frame: 30 days postoperatively ]
Central Contacts
- Megan S Melland-Smith, MD3129071414
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 |
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