Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01211067
Status:
COMPLETED
Last Update Posted:
2010-09-29
First Post:
2010-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A 1 cm tissue sample of the internal inguinal ring taken during elective hernioplasty'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-28', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histology of the internal inguinal ring', 'timeFrame': '6 months', 'description': 'Histology and histological findings of the internal inguinal ring in patients submitted to elective surgical reparation of an indirect inguinal hernia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal hernia', 'Inguinal ring', 'Histology', 'Hernioplasty', 'Lichtenstein'], 'conditions': ['Indirect Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '20437189', 'type': 'BACKGROUND', 'citation': 'Barria C, Beltran MA, Contreras MA, Cruces KS. Histology of the internal inguinal ring: it is really a novelty? Hernia. 2010 Jun;14(3):339-40. doi: 10.1007/s10029-010-0661-4. Epub 2010 May 1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with indirect inguinal hernia submitted to elective surgery with the Lichtenstein hernioplasty technique', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male gender\n* Older than 15 years-of-age\n* Unilateral indirect inguinal hernia\n* Non-smokers\n* Non-diabetics\n* Non-connective tissue conditions\n* Primary inguinal hernia\n\nExclusion Criteria:\n\n* Female gender\n* Younger than 15 years-of-age\n* Bilateral inguinal hernia\n* Direct or combined direct-indirect inguinal hernia\n* Femoral hernia\n* Smokers\n* Diabetics\n* Other connective tissue diseases\n* Recurrent inguinal hernia'}, 'identificationModule': {'nctId': 'NCT01211067', 'briefTitle': 'Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Cirujanos la Serena'}, 'officialTitle': 'Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia', 'orgStudyIdInfo': {'id': 'HLS-0015-1109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients age: 15 - 40 years-old', 'description': 'Patients within the 15 to 40 years-old age-group', 'interventionNames': ['Procedure: Lichtenstein hernioplasty']}, {'label': 'Patients age: 41 to 60 years-old', 'description': 'Patients within the group-age from 41 to 60 years-old', 'interventionNames': ['Procedure: Lichtenstein hernioplasty']}, {'label': 'Patients age: older than 61 years-old', 'description': 'Patients within the group-age from 61 years-old and older', 'interventionNames': ['Procedure: Lichtenstein hernioplasty']}], 'interventions': [{'name': 'Lichtenstein hernioplasty', 'type': 'PROCEDURE', 'description': '* Mesh hernioplasty\n* Ultrapro mesh (Ethicon, Johnson \\& Johnson)', 'armGroupLabels': ['Patients age: 15 - 40 years-old', 'Patients age: 41 to 60 years-old', 'Patients age: older than 61 years-old']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'IV REGION', 'city': 'La Serena', 'state': 'Coquimbo Region', 'country': 'Chile', 'facility': 'Hospital de La Serena', 'geoPoint': {'lat': -29.90591, 'lon': -71.25014}}, {'city': 'La Serena', 'state': 'Coquimbo Region', 'country': 'Chile', 'facility': 'Hospital de La Serena', 'geoPoint': {'lat': -29.90591, 'lon': -71.25014}}], 'overallOfficials': [{'name': 'Marcelo A Beltrán, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de La Serena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cirujanos la Serena', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marcelo A. Beltrán', 'oldOrganization': 'Hospital de La Serena'}}}}