Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Conditions
Keywords
Occult inguinal hernia, Asymptomatic inguinal hernia, Minimally invasive inguinal hernia repair, Transabdominal preperitoneal inguinal hernia repair
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.
Detailed description
This is a multicenter randomized controlled trial evaluating two management strategies - watchful waiting versus immediate repair - for occult contralateral inguinal hernias discovered during minimally invasive unilateral inguinal hernia repair. The management of occult inguinal hernias discovered at the time of laparoscopic inguinal hernia repair remains controversial. Many surgeons advocate for immediate repair during the index operation as this prevents reoperation as patients risk hernia progression and developing symptoms in the future. Others refrain from repair given that this occult hernia is asymptomatic and does not justify the risk of complications, including chronic pain, associated with repair. Currently there is no level 1 evidence to guide decision making for immediate repair versus watchful waiting. We plan to conduct at randomized, multi-center, non-inferiority trial to establish if immediate repair is non-inferior to watchful waiting in short term 30-day quality of life. Patients will be randomized intraoperatively once an occult contralateral inguinal hernia is identified. Patients will be followed up at 30-day, 1 and 2 years. In the watchful waiting group, occult hernia-related complications and those requiring repair will be captured.
Interventions
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.
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
We will enroll all adult patients with a unilateral symptomatic inguinal hernia who are suitable for a minimally invasive inguinal hernia repair. Once in the operating room and pneumoperitoneum is established, patients identified to have an occult contralateral inguinal hernia will be kept in the study. Those patients consented but without an occult inguinal hernia will be removed from the study at that point and considered screen failures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day (±15) post-operative quality of life | 30 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of occult hernias that require repair as well as occult hernia related emergencies. | 2 years | 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. |
| Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years. | 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. |
| Difference in rate of wound complications at 30-days (±15) following surgery. | 30-days | 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. |
| Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years. | 2 years | We will collect rate of readmissions and the cause for readmission as well as any medical complications and reasons for reoperation. |
| Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days. | 30 days | At the 30-day follow-up appointment, the researchers will collect number and dose of opioids prescribed as well at opioids consumed in the last 30-days. |
| Evaluate difference in inguinal hernia recurrence at 1and 2 years following surgery. | 2 years | Hernia recurrence will be determined using the current consensus score. This includes an algorithm previously described involving evaluation of CT scan, clinical exam, and Ventral Hernia Recurrence Inventory, a validated questionnaire using patient-reported outcomes to determine hernia recurrence after repair. |
| Evaluate chronic groin pain at 1 and 2 years using the pain domain of the EuraHS score. | 2 years | Pain scores from the EuraHS will be collected at 1 and 2 years. These scores will be extrapolated to determine on-going pain suggestive of chronic groin pain. |
| Perform a formal cost effectiveness analysis utilizing incremental cost effectiveness ratios. | 2 years | Costs will be compared as continuous variables using a student's t-test. Cost data will be obtained from Northwestern and will include direct costs. Direct costs for the index operation will include operating room supply and time, anesthesia, and pharmacy. |
Countries
United States
Contacts
CONTACTMegan S Melland-Smith, MD
STUDY_DIRECTORNancy Ly, MD
Northwestern University
Outcome results
None listed