Shouldice Hospital Outcome Study

Inguinal Hernia Clinical Trial

Official title:

Shouldice Hospital Outcome Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986060
• Other study ID #: 1
• Status: Recruiting
• Start date: June 17, 2019
• Est. completion date: May 2, 2024

Study information

• Verified date: June 2022
• Source: York University
• Contact: Joel Katz, PhD
• Phone: 9999999999
• Email: jkatz[@]yorku.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
Canada	Shouldice Hospital	Thornhill	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with pain severity scores > zero at one year	Brief Pain Inventory - pain severity 0-10 numeric rating scale. Typically score >= 4 corresponds to moderate-to severe pain severity	one-year post surgery
Primary	Proportion of participants with pain-related interference in multiple life domains	Brief Pain Inventory - pain interference	one-year post surgery
Primary	Proportion of participants with neuropathic pain symptoms	ID Pain 6-items total score ranges from 0 to 6	one year
Secondary	proportion of participants with significant symptoms of anxiety, depression	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	one-year post surgery
Secondary	Do preoperative perceived stress scores predict pain incidence, severity, and/or interference	Stress Assessment Test - no norms at present. Scale developed by authors and being validated.	one-year
Secondary	Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference	Connor-Davidson Resilience Scale-2. Total score ranges from 0-8. There are no clinical cut-offs for this scale	one-year
Secondary	Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference	Pain Catastrophizing Scale -4 item. Total score range: 0-16. There are no sub scales and no cut-offs for this scale	one year