Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT04806828
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes
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': 'ACTUAL', 'count': 400}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': 'Rate of postoperative complications'}], 'secondaryOutcomes': [{'measure': 'Lenght of operation', 'timeFrame': 'Intraoperative', 'description': 'Minutes of operation'}, {'measure': 'Recurrences', 'timeFrame': '1 year', 'description': 'Recurrences during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inguinal Hernia', 'Preoperative Score', 'Kingsnorth Score'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for a primary repair of inguinal hernia', 'genderDescription': 'Inguinal hernia are more frequent in men and different characteristics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male sex\n* Age \\> 18 years\n* Primary inguinal hernia\n* Unilateral hernia\n* Elective surgery\n\nExclusion Criteria:\n\n* Recurrent inguinal hernia'}, 'identificationModule': {'nctId': 'NCT04806828', 'acronym': 'POINTHER', 'briefTitle': 'Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Mar'}, 'officialTitle': 'Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes', 'orgStudyIdInfo': {'id': 'POINTHER'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HF', 'description': 'Preoperative classification of inguinal hernia', 'interventionNames': ['Other: Preoperative classification']}], 'interventions': [{'name': 'Preoperative classification', 'type': 'OTHER', 'description': 'Score of inguinal hernia', 'armGroupLabels': ['HF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08031', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'José Antonio Pereira', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'José Antonio Pereira', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parc de Salut Mar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital del Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultat of Surgery', 'investigatorFullName': 'José A. Pereira', 'investigatorAffiliation': 'Hospital del Mar'}}}}