Clinical trial NCT03986060: Shouldice Hospital Outcome Study
Official title: Shouldice Hospital Outcome Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with pain severity scores > zero at one year
timeFrame: one-year post surgery
measure: Proportion of participants with pain-related interference in multiple life domains
timeFrame: one-year post surgery
measure: Proportion of participants with neuropathic pain symptoms
timeFrame: one year
Secondary outcomes:
measure: proportion of participants with significant symptoms of anxiety, depression
timeFrame: one-year post surgery
measure: Do preoperative perceived stress scores predict pain incidence, severity, and/or interference
timeFrame: one-year
measure: Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference
timeFrame: one-year
measure: Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference
timeFrame: one year
Other outcomes:
Locations:
city: Thornhill
country: Canada
facility: Shouldice Hospital
state: Ontario
Study officials:
affiliation: York University
name: Joel Katz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shouldice Hospital
name: Robert BenDavid, MD
role: PRINCIPAL_INVESTIGATOR
References: