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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
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
Procedure/SurgeryPatients 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
Procedure/SurgeryPatients 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.
Treatment groups
380 Participants
are divided into 2 treatment groupsGroup A: Immediate occult hernia repair groupActive comparator 1 intervention
Group B: Watchful waiting occult hernia groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day (±15) post-operative quality of life
At 30 days postoperatively, patients will see their operating surgeon and will undergo a physical exam and complete a EuraHS survey as is standard of care. The EuraHS Quality of Life Score, validated for inguinal hernia patients, allows quantification of pain, physical restriction, and cosmetic satisfaction-domains directly affected by surgical intervention.
Time frame
30 days postoperativelySecondary outcomes
1
Rate of occult hernias that require repair as well as occult hernia related emergencies.
The researchers will assess the rate of occult hernias that require repair as well as occult hernia related emergencies (incarceration, strangulation or obstruction) in the watchful waiting group over the 2 year follow-up period.
Time frame
2 years2
Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years.
At 1 and 2 years patients will see their operating surgeon and will undergo a physical exam and EuraHS survey as is standard of care.
Time frame
2 years3
Difference in rate of wound complications at 30-days (±15) following surgery.
Wound events are defined as surgical site infection (SSI), surgical site occurrence (SSO) and surgical site occurrence requiring procedural intervention (SSOPI), as defined by the Ventral Hernia Working Group. Wound events will be assessed by physical exam or virtual evaluation at 30 (± 15) days.
Time frame
30-days4
Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years.
We will collect rate of readmissions and the cause for readmission as well as any medical complications and reasons for reoperation.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov