Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT00162604
Status:
UNKNOWN
Last Update Posted:
2006-09-11
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotic Treatment During Vaginal Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}, {'id': 'D052858', 'term': 'Cystocele'}, {'id': 'D020047', 'term': 'Rectocele'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002444', 'term': 'Cefuroxime'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-02', 'lastUpdateSubmitDate': '2006-09-08', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively'}]}, 'conditionsModule': {'keywords': ['Prophylactic antibiotic', 'Postoperative infections', 'Uterine prolapse grade I - II', 'cystocele', 'rectocele', 'enterocele', 'defects of the perineal body'], 'conditions': ['Uterine Prolapse', 'Cystocele', 'Rectocele', 'Enterocele']}, 'descriptionModule': {'briefSummary': 'Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.\n\nThe objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.\n\nExclusion Criteria:\n\n* Patients allergic to cefuroxime.\n* Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard.\n* Patients suffering from physical or mental disorders that will not allow them to give informed consent.\n* Pregnant and nursing women.'}, 'identificationModule': {'nctId': 'NCT00162604', 'briefTitle': 'Prophylactic Antibiotic Treatment During Vaginal Repair', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Antibiotikaprofylakse Ved Vaginalplastik', 'orgStudyIdInfo': {'id': '2602-415'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cefuroxime', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Marianne Ottesen, M.D', 'role': 'CONTACT', 'email': 'marianne.8sen@dadlnet.dk', 'phone': '0045 36323632', 'phoneExt': '3540'}, {'name': 'Tina Olsen, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abelone Elisabeth Sakse, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marianne Ottesen, M.D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Marianne Ottesen, M.D', 'role': 'CONTACT', 'email': 'marianne.8sen@dadlnet.dk', 'phone': '0045 36323632', 'phoneExt': '3540'}], 'overallOfficials': [{'name': 'Marianne Ottesen, M.D, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}}}}