Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT04730492
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HErnias REparation After Kidney Transplantation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disembowelment number in FIG / D', 'timeFrame': '1 day', 'description': 'disembowelment number in FIG / D'}], 'secondaryOutcomes': [{'measure': 'type of wall closure technique in the context of a kidney transplant', 'timeFrame': '1 day', 'description': 'type of wall closure technique in the context of a kidney transplant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal transplantation', 'post incision hernia'], 'conditions': ['Prosthesis User', 'Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.', 'detailedDescription': 'In the scientific literature, the percentage of post incisional hernia in kidney transplanted patients is very variable, and not too well-argued, especially in the context of prevention and individuation of risk factors.\n\nThe increase of surgical management of hernias reparation in renal transplant patients justifies the start of a mon-centric type study. The investigators will look for risk factors with a retrospective, observational study, by analyzing the type of surgical repair of their post-surgical wall defect.\n\nThe analysis of costs/benefits on postoperative, intraoperative, or preoperative prevention will be taken into account.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who have received renal transplantation with post-incisionale hernia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- hernia post renal transplantation\n\nExclusion criteria:\n\n\\- underage'}, 'identificationModule': {'nctId': 'NCT04730492', 'acronym': 'HEREKT', 'briefTitle': 'HErnias REparation After Kidney Transplantation Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant', 'orgStudyIdInfo': {'id': 'RECHMPL20_0594'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal Transplantation', 'description': 'Renal Transplantation'}, {'label': 'Hernias reparation post renal transplantation', 'description': 'Hernias reparation post renal transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Fabrizio PANARO, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH MONTPELLIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}