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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The population under study comprises patients recruited from Shouldice Hospital undergoing inguinal hernia repair. We aim to recruit a sample size of 3,000 patients, males and females, ages 18-90 years, all nationalities and races, capable of speaking and reading English, in good general health, there is no geographic location constraint.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joel Katz, PhD | Contact | 9999999999 | jkatz@yorku.ca | |
| Marguerite Mainprize | Contact | 905 889 1125 | 297 | research@shouldice.com |
| Name | Affiliation | Role |
|---|---|---|
| Joel Katz, PhD | York University | Principal Investigator |
| Robert BenDavid, MD | Shouldice Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shouldice Hospital | Recruiting | Thornhill | Ontario | L3T4A3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40780873 | Derived | Mainprize M, Svendrovski A, Paasch C, Yilbas A, Katz J. Matching males and females undergoing Shouldice repair using a prospective, longitudinal design. Can J Surg. 2025 Aug 8;68(4):E325-E332. doi: 10.1503/cjs.012824. Print 2025 Jul-Aug. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |