Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-30 @ 5:07 AM
Study NCT ID:
NCT05534503
Status:
UNKNOWN
Last Update Posted:
2022-09-10
First Post:
2022-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infection after drainage in contact with a retromuscular prosthesis', 'timeFrame': '1 day after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eventration of the abdominal wall', 'Hernia', 'Drainage', 'Retromuscular position', 'Digestive surgery'], 'conditions': ['Eventration of the Abdominal Wall']}, 'descriptionModule': {'briefSummary': 'Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (≥18 years old) operated on at HUS between 01/01/2018 and 12/31/2020', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patient (≥18 years old)\n* Patient operated on at HUS between 01/01/2018 and 12/31/2020\n* Patient who has undergone surgical cure of anterior or lateral abdominal wall eventration of any width with placement during the procedure of a prosthetic mesh in a prefascial retromuscular position.\n* Patient not objecting to the reuse of their data for scientific research purposes.\n\nExclusion criteria:\n\n* Patient who has expressed opposition to the reuse of his or her data for scientific research purposes.\n* Particular clinical forms of the disease: absence of previous surgical intervention (and thus absence of ventration: umbilical hernia, diastasis)\n* Absence of prosthesis during the operation or prosthesis placed in intraperitoneal position'}, 'identificationModule': {'nctId': 'NCT05534503', 'acronym': 'Drain-IHR', 'briefTitle': 'Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?', 'orgStudyIdInfo': {'id': '8704'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit ROMAIN, MD, PhD', 'role': 'CONTACT', 'email': 'benoit.romain@chru-strasbourg.fr', 'phone': '33 3 88 12 72 37'}, {'name': 'Benoit ROMAIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vincent LOUIS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samer DIAB, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de chirurgie générale et digestive - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Benoit ROMAIN, MD, PhD', 'role': 'CONTACT', 'email': 'benoit.romain@chru-strasbourg.fr', 'phone': '33 3 88 12 72 37'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}