Shouldice Hospital Outcome Study

York University

Status: Enrolling

Conditions: Inguinal Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT03986060

1

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.