Shouldice Hospital Outcome Study

Study Overview
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Brief Summary
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A prospective cohort study recruiting participants from the Shouldice Hospital. The study population consists of healthy patients electing to receive hernia surgery for a primary inguinal hernia on an inpatient basis. The goal of this study is to determine the incidence of hernia pain and its intensity as well as other related outcomes up to one year after primary unilateral inguinal hernia repair.

Official Title
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Shouldice Hospital Outcome Study

Conditions
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Inguinal Hernia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent form. Willing to comply with all study procedures and be available for the duration of the study (patients have fixed address, access to phone, email, internet, and/or a computer) Male or female, aged 18 to 90 years. Subjects having surgery on a primary unilateral inguinal hernia In good general health as evidenced by medical history Capable of speaking and reading English sufficiently well to complete the questionnaires Exclusion Criteria: Surgery is deemed an emergency procedure (any obstruction, incarceration or irreducible hernias). Other abdominal hernias being operated on at the same time or surgery is planned during the follow-up period (incisional and umbilical hernias) If hernia recurs within the study period and there is a reoperation within the year BMI >40kg/m2 Patients unable to understand English, written and spoken Patients with collagen or connective tissue disorders Local (site of surgery) or systemic infection Any known diseases that impair nerve function Patients who end up getting a mesh repair during surgery Impairment of cognitive function (e.g. dementia) Pregnancy or lactation Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with pain severity scores > zero at one year | Brief Pain Inventory - pain severity 0-10 numeric rating scale. Typically score >= 4 corresponds to moderate-to severe pain severity | one-year post surgery | 
| Proportion of participants with pain-related interference in multiple life domains | Brief Pain Inventory - pain interference | one-year post surgery | 
| Proportion of participants with neuropathic pain symptoms | ID Pain 6-items total score ranges from 0 to 6 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of participants with significant symptoms of anxiety, depression | Patient Health Questionnaire for Depression and Anxiety - PHQ-4 total score range from 0-12; anxiety subscale 0-6; depression subscale 0-6. total score cutoffs: 0-2 normal; 3-5 mild; 6-8 moderate; 9-12 severe | one-year post surgery | 
| Do preoperative perceived stress scores predict pain incidence, severity, and/or interference | Stress Assessment Test - no norms at present. Scale developed by authors and being validated. | one-year | 
| Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference | Connor-Davidson Resilience Scale-2. Total score ranges from 0-8. There are no clinical cut-offs for this scale | one-year | 
| Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference | Pain Catastrophizing Scale -4 item. Total score range: 0-16. There are no sub scales and no cut-offs for this scale | one year |