Shouldice Hospital Outcome Study

NCT03986060 | Unknown

• 1 other identifier: 1
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• proportion of participants with significant symptoms of anxiety, depression

  one-year post surgery

• Do preoperative perceived stress scores predict pain incidence, severity, and/or interference

  one-year

• Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference

  one-year

• Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference

  one year

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• York University: lead

Study Sites (1)

Shouldice Hospital

Thornhill, Ontario, L3T4A3, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 40780873 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Katz, PhD

  York University

  PRINCIPAL INVESTIGATOR

• Robert BenDavid, MD

  Shouldice Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Katz, PhD

CONTACT

9999999999; jkatz@yorku.ca

Marguerite Mainprize

CONTACT

905 889 1125; research@shouldice.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 14, 2019
• Study Start: June 17, 2019
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2024
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

CA (1)