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Shouldice Hospital Outcome Study

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ClinicalTrials.gov Identifier: NCT03986060
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Joel Katz, York University

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.

Condition or disease
Inguinal Hernia

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shouldice Hospital Outcome Study
Estimated Study Start Date : June 17, 2019
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : June 17, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of participants with pain severity scores > zero at one year [ Time Frame: one-year post surgery ]
    Brief Pain Inventory - pain severity 0-10 numeric rating scale. Typically score >= 4 corresponds to moderate-to severe pain severity

  2. Proportion of participants with pain-related interference in multiple life domains [ Time Frame: one-year post surgery ]
    Brief Pain Inventory - pain interference

  3. Proportion of participants with neuropathic pain symptoms [ Time Frame: one year ]
    ID Pain 6-items total score ranges from 0 to 6


Secondary Outcome Measures :
  1. proportion of participants with significant symptoms of anxiety, depression [ Time Frame: one-year post surgery ]
    Patient Health Questionnaire for Depression and Anxiety - PHQ-4 total score range from 0-12; anxiety subscale 0-6; depression subscale 0-6. total score cutoffs: 0-2 normal; 3-5 mild; 6-8 moderate; 9-12 severe

  2. Do preoperative perceived stress scores predict pain incidence, severity, and/or interference [ Time Frame: one-year ]
    Stress Assessment Test - no norms at present. Scale developed by authors and being validated.

  3. Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference [ Time Frame: one-year ]
    Connor-Davidson Resilience Scale-2. Total score ranges from 0-8. There are no clinical cut-offs for this scale

  4. Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference [ Time Frame: one year ]
    Pain Catastrophizing Scale -4 item. Total score range: 0-16. There are no sub scales and no cut-offs for this scale



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986060


Contacts
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Contact: Joel Katz, PhD 9999999999 jkatz@yorku.ca
Contact: Marguerite Mainprize 905 889 1125 ext 297 research@shouldice.com

Sponsors and Collaborators
York University
Investigators
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Principal Investigator: Joel Katz, PhD York University
Principal Investigator: Robert BenDavid, MD Shouldice Hospital

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Responsible Party: Joel Katz, Professor, York University
ClinicalTrials.gov Identifier: NCT03986060     History of Changes
Other Study ID Numbers: 1
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hernia, Inguinal
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical