Shouldice Hospital Outcome Study

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Joel Katz, PhD; Phone Number: 9999999999; Email: jkatz@yorku.ca
• Study Contact Backup: Name: Marguerite Mainprize; Phone Number: 297 905 889 1125; Email: research@shouldice.com

Study Locations

• Canada
  • Ontario
    • Thornhill, Ontario, Canada, L3T4A3
      • Recruiting
      • Shouldice hospital
      • Contact: Marguerite Mainprize, MSc; Phone Number: 297 905 889 1125; Email: mmainprize@shouldice.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: York University
• Investigators: Principal Investigator: Joel Katz, PhD, York University; Principal Investigator: Robert BenDavid, MD, Shouldice hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Anticipated): May 2, 2023
• Study Completion (Anticipated): May 2, 2024

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No