Recruiting

Repair vs. Monitoring

Sponsor:

Northwestern University

Code:

NCT07461558

Conditions

Inguinal Hernia Bilateral

Inguinal Hernia Unilateral

Eligibility Criteria

Sex: All

Age: 18+

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

Watchful waiting with supportive care

Study Details

Brief summary:

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.

Conditions

Inguinal Hernia Bilateral

Inguinal Hernia Unilateral

Study ID

NCT07461558

Start date

Apr 1, 2026

Status verified date

Mar, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients ≥18 years old
  • Symptomatic unilateral inguinal hernia
  • Occult contralateral hernia identified intraoperatively
  • Ability to provide informed consent

Exclusion Criteria:

  • Prior contralateral inguinal hernia repair
  • Symptomatic, bilateral inguinal hernias confirmed on physical exam
  • Contraindications to general anesthesia or surgery
  • Urgent or emergent presentations
  • Adults unable to consent
  • Pregnant patients

Study Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Immediate occult hernia repair group

Patients 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 group

Patients 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.

Interventions

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Patients 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

Patients 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.

Primary outcome measure

  • 30-day (±15) post-operative quality of life [ Time Frame: 30 days postoperatively ]

Central Contacts and Locations

Central contacts

Megan S Melland-Smith, MD

3129071414megan.mellandsmith@nm.org

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Megan Melland-Smith, MD

3129071414megan.mellandsmith@nm.org

Nancy Ly, MD

2624551560nancy.ly@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Jun 26, 2026

Last verified

Mar, 2026

Keywords

  • Occult inguinal hernia
  • Asymptomatic inguinal hernia
  • Minimally invasive inguinal hernia repair
  • Transabdominal preperitoneal inguinal hernia repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-26.