Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-04-18 @ 4:30 PM
Study NCT ID:
NCT06530420
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1087}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-28', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of umbilical hernia recurrence', 'timeFrame': '20.12.2025'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retrospective Analysis of Material From the Hospital Database']}, 'referencesModule': {'references': [{'pmid': '41171115', 'type': 'DERIVED', 'citation': 'Kantor N, Gach T, Orzeszko Z, Kaciczak M, Frycz J, Solecki R, Markowska B, Bogacki P, Szura M. The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of the Method of Their Treatment. Pol Przegl Chir. 2025 Jul 29;97(5):25-30. doi: 10.5604/01.3001.0055.2300.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients.\n\nThe study is conducted as a retrospective analysis of material from the hospital database', 'detailedDescription': 'A retrospective analysis will include patients operated on in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022. The incidence of recurrence will be assessed based on outpatient records and a telephone survey. Hernias will be classified according to the EHS/AHS guidelines as small, medium and large. The qualification will take into account the old and new classification of hernias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with umbilical hernia operated in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Repair surgery for primary umbilical hernia\n\nExclusion Criteria:\n\n* Repair surgery for recurrent umbilical hernia'}, 'identificationModule': {'nctId': 'NCT06530420', 'briefTitle': 'The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Brothers Hospitallers Hospital in Cracow'}, 'officialTitle': 'The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment', 'orgStudyIdInfo': {'id': '118.0043.1.167.2024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Umbilical hernia repair surgery', 'type': 'PROCEDURE', 'description': 'collected information about: gender, age, comorbidities, body weight, time of surgery, hernia size and treatment methods and reccurence'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Nicole Kantor', 'role': 'CONTACT', 'phone': '668735181'}], 'facility': 'Hospital of the Brothers Hospitallers of Saint John of God', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'centralContacts': [{'name': 'Nicole Kantor', 'role': 'CONTACT', 'email': 'nkantor@interia.pl', 'phone': '668735181'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brothers Hospitallers Hospital in Cracow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Nicole Kantor', 'investigatorAffiliation': 'Brothers Hospitallers Hospital in Cracow'}}}}