Treatment of Occult Inguinal Hernias

Study Overview
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Brief Summary
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Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.

Official Title
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Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Occcult hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia Exclusion Criteria: Patient has life expectancy of less than 2 years Patients unlikely to follow-up (e.g. live out of state, unable to be reached by phone/e-mail Non-English and Non-Spanish speakers Pregnant or breast-feeding patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery<br>Occult hernia found will be repaired at the same time as the initial inguinal hernia | Procedure: Occcult hernia repair<br>* The occult hernia will be repaired during the same inguinal hernia repair<br>|
| No Intervention: Expectant Management<br>No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient threshold value for need for future surgery in order to accept Expectant Management (EM) of an Occult Inguinal Hernia (OIH) determined using standard gamble technique | Assessed by using a decision tool (standard gamble method) that will be developed using information gathered at 1 year post-operative | From Baseline up to 2 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who develop any surgical complication | Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions | 30 days post-operative | 
| Hernia recurrence | recurrence of hernia | 2 years post-operative | 
| Operative re-intervention | Number of patients who had to have another surgery to repair their hernia | 1 years post-operative | 
| Assessment of chronic pain | Pain assessed by a validated visual assessment score | 1 year post-operative | 
| Progression of hernia signs or symptoms | Will be assessed by the physician during the 1 year post-operative abdominal exam visit | 1 year post-operative | 
| Change in Abdominal wall quality of life (AW-QOL) | Hernia-related Quality of Life Survey (HerQLes) will be used to assess this. Consists of 12 statements that the patient will rate how much he/she agrees with each statement. They will rate each statement from 1 (Strongly Disagree) to 10 (strongly agree). These 12 ratings will be combined to form one score. | From Baseline up to 2 years post-operative | 
| Number of patients with an occult inguinal hernia | Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery | Time of surgery | 
| Groin pain on occult hernia side | Pain assessed by a validated visual assessment score | 1 month and 1 year post-operative | 
| Time duration for surgery | Assessed by looking at the total time for the surgery to repair the inguinal hernia(s) | Time of surgery | 
| Time off work due to the hernia surgery | The amount of time (days) patients had to take time off from work for the hernia surgery | Baseline to 2 years post-operative | 
| Time to resume normal activity from any hernia surgery | The amount of time (days) it took for patients to resume their normal activities following hernia surgery | Baseline to 2 years post-operative | 
| Satisfaction with Decision Scale | A decision scale looking at risk vs. benefit of hernia surgery will be done with patients | Baseline to 2 years post-operative |