Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT03517202
Status:
UNKNOWN
Last Update Posted:
2018-06-04
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The investigators compared the rate of complications after TVT surgery depending on the type of anesthesia and the need for urinary catheterization, requiring longer hospital stay after surgery.', 'timeFrame': 'The period from January 1st, 2012 to December 31st, 2016 will be examined', 'description': 'Patients hospitalized at Strasbourg University Hospital from 2012 to 2016.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urologic surgery', 'Urinary incontinence', 'Tension Free Vaginal Tape', 'Post-operative urinary retention', 'Outpatient surgery'], 'conditions': ['Urinary Retention']}, 'descriptionModule': {'briefSummary': 'Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.\n\nThe investigators compared the complication rate after TVT surgery depending on the type of anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Sex: Female\n* Patient who has consented to the use of her medical data for research purposes.\n* Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016\n\nExclusion Criteria:\n\n* Specific clinical forms of the disease,\n* Interfering treatments and associated diseases, history,\n* Refusal of the patient to participate in the study'}, 'identificationModule': {'nctId': 'NCT03517202', 'briefTitle': 'Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia', 'orgStudyIdInfo': {'id': '7001'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valentina FAITOT, MD', 'role': 'CONTACT', 'email': 'valentina.faitot@chru-strasbourg.fr', 'phone': '33 3 88 12 70 75'}, {'name': 'Gauthier VINEE, MD', 'role': 'CONTACT', 'email': 'gauthieremmanuel.vinee@chru-strasbourg.fr', 'phone': '33 3 88 12 70 75'}, {'name': 'Valentina FAITOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gauthier VINEE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Anesthésiologie - Réanimation", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Valentina FAITOT, MD', 'role': 'CONTACT', 'email': 'valentina.faitot@chru-strasbourg.fr', 'phone': '03 88 12 70 75'}, {'name': 'Gauthier VINEE, MD', 'role': 'CONTACT', 'email': 'gauthieremmanuel.vinee@chru-strasbourg.fr', 'phone': '03 88 12 70 75'}], 'overallOfficials': [{'name': 'Valentina FAITOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}