Shouldice Hospital Outcome Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-17

Study Completion Date

2024-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No