Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 2:53 AM
Study NCT ID:
NCT03986060
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shouldice Hospital Outcome Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2019-06-12', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with pain severity scores > zero at one year', 'timeFrame': 'one-year post surgery', 'description': 'Brief Pain Inventory - pain severity 0-10 numeric rating scale. Typically score \\>= 4 corresponds to moderate-to severe pain severity'}, {'measure': 'Proportion of participants with pain-related interference in multiple life domains', 'timeFrame': 'one-year post surgery', 'description': 'Brief Pain Inventory - pain interference'}, {'measure': 'Proportion of participants with neuropathic pain symptoms', 'timeFrame': 'one year', 'description': 'ID Pain 6-items total score ranges from 0 to 6'}], 'secondaryOutcomes': [{'measure': 'proportion of participants with significant symptoms of anxiety, depression', 'timeFrame': 'one-year post surgery', 'description': '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'}, {'measure': 'Do preoperative perceived stress scores predict pain incidence, severity, and/or interference', 'timeFrame': 'one-year', 'description': 'Stress Assessment Test - no norms at present. Scale developed by authors and being validated.'}, {'measure': 'Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference', 'timeFrame': 'one-year', 'description': 'Connor-Davidson Resilience Scale-2. Total score ranges from 0-8. There are no clinical cut-offs for this scale'}, {'measure': 'Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference', 'timeFrame': 'one year', 'description': 'Pain Catastrophizing Scale -4 item. Total score range: 0-16. There are no sub scales and no cut-offs for this scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '40780873', 'type': 'DERIVED', 'citation': 'Mainprize M, Svendrovski A, Paasch C, Yilbas A, Katz J. Matching males and females undergoing Shouldice repair using a prospective, longitudinal design. Can J Surg. 2025 Aug 8;68(4):E325-E332. doi: 10.1503/cjs.012824. Print 2025 Jul-Aug.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide signed and dated informed consent form.\n* 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)\n* Male or female, aged 18 to 90 years.\n* Subjects having surgery on a primary unilateral inguinal hernia\n* In good general health as evidenced by medical history\n* Capable of speaking and reading English sufficiently well to complete the questionnaires\n\nExclusion Criteria:\n\n* Surgery is deemed an emergency procedure (any obstruction, incarceration or irreducible hernias).\n* Other abdominal hernias being operated on at the same time or surgery is planned during the follow-up period (incisional and umbilical hernias)\n* If hernia recurs within the study period and there is a reoperation within the year\n* BMI \\>40kg/m2\n* Patients unable to understand English, written and spoken\n* Patients with collagen or connective tissue disorders\n* Local (site of surgery) or systemic infection\n* Any known diseases that impair nerve function\n* Patients who end up getting a mesh repair during surgery\n* Impairment of cognitive function (e.g. dementia)\n* Pregnancy or lactation\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study."}, 'identificationModule': {'nctId': 'NCT03986060', 'briefTitle': 'Shouldice Hospital Outcome Study', 'organization': {'class': 'OTHER', 'fullName': 'York University'}, 'officialTitle': 'Shouldice Hospital Outcome Study', 'orgStudyIdInfo': {'id': '1'}}, 'contactsLocationsModule': {'locations': [{'zip': 'L3T4A3', 'city': 'Thornhill', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marguerite Mainprize, MSc', 'role': 'CONTACT', 'email': 'mmainprize@shouldice.com', 'phone': '905 889 1125', 'phoneExt': '297'}], 'facility': 'Shouldice Hospital', 'geoPoint': {'lat': 43.80011, 'lon': -79.4163}}], 'centralContacts': [{'name': 'Joel Katz, PhD', 'role': 'CONTACT', 'email': 'jkatz@yorku.ca', 'phone': '9999999999'}, {'name': 'Marguerite Mainprize', 'role': 'CONTACT', 'email': 'research@shouldice.com', 'phone': '905 889 1125', 'phoneExt': '297'}], 'overallOfficials': [{'name': 'Joel Katz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York University'}, {'name': 'Robert BenDavid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shouldice Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joel Katz', 'investigatorAffiliation': 'York University'}}}}