Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 8:38 AM
Study NCT ID:
NCT05125692
Status:
UNKNOWN
Last Update Posted:
2021-11-18
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Repair of Post Cesarean Istmocele
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'WOMEN IN CHILDBEARING PERIOD WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-06', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-11-06', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myometrial thickness in supracervical area', 'timeFrame': 'at 1 month postoperative', 'description': 'the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Disease']}, 'descriptionModule': {'briefSummary': '20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.', 'detailedDescription': "METHODS:\n\n* Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)\n* Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:\n\n 1. Distance from the external cervical os to the lower end of the isthmocele (A)\n 2. Distance from the external cervical os to the upper end of the isthmocele(B)\n 3. Length of the isthmocele (B-A)\n 4. Residual myometrial thickness (the least) of the isthmocele.\n* Routine preoperative workup.\n* The technique:\n\n * Postmenstrual\n * Spinal anesthesia\n * Sterilization of the perineum and vagina\n * Cervical dilation up to 8mm using Hegar's dilators\n * Marking the previously measured points A \\& B\n * Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.\n * The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.\n * Hemostasis is performed using diathermy.\n * The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures\n* The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.\n* Sexual intercourse is avoided for 4 weeks postoperative\n* postoperative transvaginal ultrasound follow up; at 1 month postoperative.\n* Data will be statistically analyzed and results will be tabulated."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women diagnosed with symptomatic post cesarean isthmocele.\n* should present with abnormal uterine bleeding .\n\nExclusion Criteria:\n\n* presence of any other uterine pathology,\n* presence of adnexal pathology,\n* presence of malignancies,\n* presence of pregnancy,\n* presence of infection in the lower genital tract ,\n* general cause of bleeding\n* women not accepting the procedure,\n* women not consented'}, 'identificationModule': {'nctId': 'NCT05125692', 'acronym': 'OWarda', 'briefTitle': 'Vaginal Repair of Post Cesarean Istmocele', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique', 'orgStudyIdInfo': {'id': 'osama Istmocele'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'women with symptomatic post cesarean Istmocele', 'description': 'vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques', 'interventionNames': ['Procedure: vaginal surgical repair of isthmocele']}], 'interventions': [{'name': 'vaginal surgical repair of isthmocele', 'type': 'PROCEDURE', 'description': 'after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach', 'armGroupLabels': ['women with symptomatic post cesarean Istmocele']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlya Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'osama m warda, MD', 'role': 'CONTACT', 'email': 'osamawarda@mans.edu.eg', 'phone': '01066153212', 'phoneExt': '+20'}, {'name': 'osama m warda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'osama M Warda, MD', 'role': 'CONTACT', 'email': 'osamawarda@mans.edu.eg', 'phone': '01066153212', 'phoneExt': '+20'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}