Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

Qualifiers

Male or female patients ≥18 years old

Symptomatic unilateral inguinal hernia

Occult contralateral hernia identified intraoperatively

Ability to provide informed consent

Disqualifiers

Prior contralateral inguinal hernia repair

Symptomatic, bilateral inguinal hernias confirmed on physical exam

Contraindications to general anesthesia or surgery

Urgent or emergent presentations

Trial design

Treatments tested in this trial

  • 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

Treatment groups

380 Participants
are divided into 2 treatment groups

Sponsors and collaborators