Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-03-05 @ 3:46 AM
Study NCT ID:
NCT01978067
Status:
UNKNOWN
Last Update Posted:
2014-02-27
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Sexual Function of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the result of transvaginal resection of caesarean scar deficiency in affecting quality of (sex)life.', 'timeFrame': 'one year', 'description': 'two questionnaires results:FSFI and HRQoL'}], 'primaryOutcomes': [{'measure': 'The safety of transvaginal resection of caesarean scar deficiency in the treatment of PCSD', 'timeFrame': 'one week', 'description': 'blood loss, hemoglobin in the first postoperative day, operation time, preoperative and postoperative complications,change to other treatment,vaginal bleeding after surgery and length of stay are collected to evaluate the safety of this procedure.'}], 'secondaryOutcomes': [{'measure': 'the effectiveness of transvaginal resection of caesarean scar deficiency in the treatment of PCSD.', 'timeFrame': 'one year', 'description': 'Observation of menstruation in three months,six months and nine months after surgery is applied for evaluating the effectiveness of this procedure and transvaginal ultrasound,hysteroscopy and Gynecological Examination are performed after surgery.Situation of fertility ,(sex)quality of life after surgery also are very important indicator of this procedure effectiveness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uterine Scar From Previous Cesarean Delivery', 'previous caesarean scar deficiency', 'transvaginal resection', 'quality of life', 'sexual activity'], 'conditions': ['Quality of Life', 'Sexual Activity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to further demonstrate the safety , validity and quality of (sexual)life of vaginal operation for previous cesarean scar defect resection.', 'detailedDescription': "collect all the patients'clinical information,use two questionnaire (the HRQoL and FSFI)to estimate patients' general healthy and sexual function before surgery and postoperation in 1 month,3 months and 6 months"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients diagnosed PCSD scheduled for vaginal operation in The First Affiliated Hospital between December 2013 and December 2015', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preoperative diagnosed as PCSD\n* hemodynamic stability\n\nExclusion Criteria:\n\n* irregular menstrual cycle\n* using IUD\n* complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.'}, 'identificationModule': {'nctId': 'NCT01978067', 'acronym': 'PCSD', 'briefTitle': 'Quality of Life and Sexual Function of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Safety ,Validity and Quality of (Sexual)Life of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect', 'orgStudyIdInfo': {'id': 'CHEN-PCSD'}, 'secondaryIdInfos': [{'id': 'PCSD-2013', 'type': 'OTHER', 'domain': 'Hospital Ethical Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'transvaginal resection of Uterine Scar', 'description': 'transvaginal resection of Uterine Scar From Previous Cesarean Delivery', 'interventionNames': ['Procedure: transvaginal resection of Uterine Scar']}], 'interventions': [{'name': 'transvaginal resection of Uterine Scar', 'type': 'PROCEDURE', 'description': "Expose, grasp and traction the cervix. An incision was made at the anterior cervicovaginal junction, and the bladder was dissected away until the anterior peritoneal reflection was identified. The anterior drawing hook was inserted.into the vaginal incision to retract the bladder upwards. The PCSD was identified as a'fornix' located in the anterior part of the lower uterine segment. A transverse incision was made to remove the scar deficiency, and the edges of the incision were trimmed with scissors, and the myometrial and vaginal defects were closed.", 'armGroupLabels': ['transvaginal resection of Uterine Scar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Shu-Qin, M.D&Ph.D', 'role': 'CONTACT', 'email': 'chenshuqin1021@163.com', 'phone': '+862087332200', 'phoneExt': '8342'}, {'name': 'Fan Li, M.D', 'role': 'CONTACT', 'email': '37488373@qq.com', 'phone': '+862087332200', 'phoneExt': '8342'}, {'name': 'Fan Li, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Li Jing-Bo, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kong Ling-Zhi, M.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Chen Shu-Qin, PhD & MD', 'role': 'CONTACT', 'email': 'chenshuqin1021@163.com', 'phone': '+862087332200', 'phoneExt': '8342'}, {'name': 'Fan Li, M.D', 'role': 'CONTACT', 'email': '37488373@qq.com', 'phone': '+862087332200', 'phoneExt': '8342'}], 'overallOfficials': [{'name': 'Chen Shu-Qin, M.D&PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}, {'name': 'Yao Shu-Zhong, M.D&Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}, {'name': 'Fan Li, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shu-Qin Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'associate professor of gynaecology and obstetricsf', 'investigatorFullName': 'Shu-Qin Chen', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}