Shouldice Hospital Outcome Study

Last updated: June 7, 2022
Sponsor: York University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT03986060
1
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of thestudy (patients have fixed address, access to phone, email, internet, and/or acomputer)
  • 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 thequestionnaires

Exclusion

Exclusion Criteria:

  • Surgery is deemed an emergency procedure (any obstruction, incarceration orirreducible hernias).
  • Other abdominal hernias being operated on at the same time or surgery is plannedduring 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 theindividual's full compliance with or completion of the study.

Study Design

Total Participants: 3000
Study Start date:
June 17, 2019
Estimated Completion Date:
May 02, 2024

Connect with a study center

  • Shouldice Hospital

    Thornhill, Ontario L3T4A3
    Canada

    Active - Recruiting

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