Ignite Creation Date:
2025-12-26 @ 11:51 AM
Ignite Modification Date:
2026-02-23 @ 11:49 AM
Study NCT ID:
NCT02933216
Status:
UNKNOWN
Last Update Posted:
2016-10-14
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Therapeutic Effects of VR and Hysteroscope + Laparoscope in the Treatment of Cesarean Scar Diverticula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thickness of the remaining muscular layer (mm)', 'timeFrame': '6 months after surgery', 'description': 'The thickness of the remaining muscular layer is measured by transvaginal ultrasound.'}], 'secondaryOutcomes': [{'measure': 'duration of menstruation (day)', 'timeFrame': '6 months after surgery', 'description': 'The menstruation duration in CSD patients is collected 6 months after surgery.'}, {'measure': 'the length of CSD (mm)', 'timeFrame': '6 months after surgery', 'description': 'The length of CSD is measured by transvaginal ultrasound.'}, {'measure': 'the depth of CSD (mm)', 'timeFrame': '6 months after surgery', 'description': 'The depth of CSD is measured by transvaginal ultrasound.'}, {'measure': 'the width of CSD (mm)', 'timeFrame': '6 months after surgery', 'description': 'The width of CSD is measured by transvaginal ultrasound.'}]}, 'conditionsModule': {'keywords': ['Cesarean Scar Diverticula'], 'conditions': ['Cesarean Scar Diverticula']}, 'descriptionModule': {'briefSummary': 'Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. Currently, several limited surgical management procedures for CSD have been reported, such as hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope) and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cesarean section diverticula patients from Nov 2016 until June 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients are younger than 40.\n2. Clearly diagnosed with CSD.\n3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).\n4. The thickness of the remaining muscular layer of CSD was less than 3 mm.\n5. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.\n6. The medicine conservative treatment is invalid.\n7. Refusing or use birth control pills contraindications.\n8. No serious medical problems (important viscera function in the normal range).\n9. No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.\n10. No gynaecology or other malignant tumors.\n11. Sign the informed consent.\n\nExclusion Criteria:\n\n1. Over the age of 40;\n2. Indefinite diagnosis.\n3. The absence of clinical manifestations of CSD.\n4. The presence of menstrual irregularities before cesarean delivery.\n5. Coagulation disorders.\n6. Malignant tumors.\n7. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).\n8. Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.\n9. Use of intrauterine devices.\n10. Unwilling to comply with the research plan.'}, 'identificationModule': {'nctId': 'NCT02933216', 'briefTitle': 'Comparison of the Therapeutic Effects of VR and Hysteroscope + Laparoscope in the Treatment of Cesarean Scar Diverticula', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Comparison of the Therapeutic Effects of Vaginal Repair and Hysteroscopic Combined With Laparoscopic Excision in the Treatment of Cesarean Scar Diverticula', 'orgStudyIdInfo': {'id': 'CSD-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VR', 'description': 'The CSD patients are received treatment of vaginal repair.'}, {'label': 'hysteroscope + laparoscope', 'description': 'The CSD patients are received treatment of hysteroscopic combined with laparoscopic excision.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201204', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xipeng Wang, M.D., Ph.D.,', 'role': 'CONTACT', 'email': 'xipengwang@hotmail.com', 'phone': '86-13817806602'}, {'name': 'Xiaoqian Yang, M.D., Ph.D.,', 'role': 'CONTACT', 'email': 'yangxiaoqian1986@126.com', 'phone': '86-18516703569'}], 'overallOfficials': [{'name': 'Xipeng Wang, M.D., Ph.D.,', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}