Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04078802
Status:
UNKNOWN
Last Update Posted:
2019-09-09
First Post:
2019-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-09-02', 'studyFirstSubmitQcDate': '2019-09-02', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgery time', 'timeFrame': 'from admission up to 6 hours post operation', 'description': 'time of surgery'}], 'secondaryOutcomes': [{'measure': 'bleeding', 'timeFrame': 'from admission up to 6 hours post operation', 'description': 'bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.'}, {'measure': 'hospital days', 'timeFrame': 'from admission up to 96 hours post operation', 'description': 'how many days after surgery for hospitalization'}, {'measure': 'PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire', 'timeFrame': 'from admission up to 6 hours post operation', 'description': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is a scoring index used to measure sexual function of women affected by pelvic organ prolapse. range 0-48. 0 marks good sexual function and 48 measures sexual disability affected from pelvic organ prolapse'}, {'measure': 'PFDI score - Pelvic Floor Disability Index', 'timeFrame': 'from admission up to 6 hours post operation', 'description': 'The Pelvic Floor Disability Index is an index used to obtain an objective score regarding pelvic floor disability comprising of bowel, bladder, or pelvic symptoms over the last 3 months prior to answering the questionnaire. score ranges 0-300. 0 outcome is no pelvic floor disability and 300 marks a high level of pelvic floor disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Prolapse']}, 'descriptionModule': {'briefSummary': 'VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.', 'detailedDescription': 'The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'only women suffer from vaginal prolapse', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with vaginal prolapse\n* capable of having a surgery - assessed by an anesthesiologist\n* women who approve of having the surgery\n\nExclusion Criteria:\n\n* BMI over 40\n* women who have recurrent PID (pelvic inflammatory disease)\n* women with oncology records'}, 'identificationModule': {'nctId': 'NCT04078802', 'briefTitle': '0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse', 'orgStudyIdInfo': {'id': 'RambamMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VNOTES ARM', 'description': 'treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.', 'interventionNames': ['Procedure: VNOTES/VH']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal hysterectomy Arm', 'description': 'treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.', 'interventionNames': ['Procedure: VNOTES/VH']}], 'interventions': [{'name': 'VNOTES/VH', 'type': 'PROCEDURE', 'description': 'same as above', 'armGroupLabels': ['VNOTES ARM', 'Vaginal hysterectomy Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Omer Mor, mD', 'role': 'CONTACT', 'email': 'omermor23@gmail.com', 'phone': '972546486414'}], 'overallOfficials': [{'name': 'Omer Mor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Omer MOR MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}