Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-01 @ 4:45 AM
Study NCT ID:
NCT05000112
Status:
UNKNOWN
Last Update Posted:
2021-09-27
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal microbiome-host interaction in patients after TVM', 'timeFrame': 'Over 6 months postoperative'}, {'measure': 'Vaginal microbiome-host Interaction associated with mesh exposure after TVM', 'timeFrame': 'Over 6 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Difference of vaginal microbiome between groups', 'timeFrame': 'Over 6 months postoperative'}, {'measure': 'Differentially expressed genes in host-mesh interaction between groups', 'timeFrame': 'Over 6 months postoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Microbiome', 'Graft Versus Host Reaction']}, 'descriptionModule': {'briefSummary': 'Transvaginal pelvic mesh implantation（TVM） is a foreign body implantation operation with intraoperative colonization of vaginal bacteria. However, the vaginal microbiome-host interaction and its influence in the mechanism of mesh exposure after TVM remains unclear. This study will enroll post-TVM patients with and without mesh exposure and use their vaginal swabs to perform TRACE-seq and cytokine analysis. The microbiome-host interactions related with mesh exposure and the changes in protein expression will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '45 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with "III-IV degree uterine/apex/anterior vaginal wall prolapse and I-II degree of posterior vaginal wall prolapse" who agree to be treated by transvaginal pelvic mesh implantation. All surgeries were performed by surgeons with extensive experience in transvaginal mesh implantation (\\>20 vaginal mesh implantation per year) using macroporous, monofilament, polypropylene mesh.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with "III-IV degree uterine/apex/anterior vaginal wall prolapse and I-II degree of posterior vaginal wall prolapse" who agree to be treated by transvaginal pelvic mesh implantation.\n* All surgeries were performed by surgeons with extensive experience in transvaginal mesh implantation (\\>20 vaginal mesh implantation per year) using macroporous, monofilament, polypropylene mesh.\n\nExclusion Criteria:\n\n* 1\\. Have had sex in the past 5 days or had vaginal irrigation;\n* 2\\. Use oral or vaginal antibiotics, antifungal, immunosuppressant, hormone drugs or probiotics for the last 30 days.\n* 3\\. Combined with immunosuppressive diseases, diseases with contraindication of vaginal estrogen such as breast cancer, endometrial cancer.\n* 4\\. If the patient has a uterus before surgery and does not undergo total transvaginal hysterectomy during surgery,\n* 5\\. Intraoperative bladder injury or intraoperative hemorrhage \\>500ml or postoperative hematoma.'}, 'identificationModule': {'nctId': 'NCT05000112', 'briefTitle': 'Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation', 'orgStudyIdInfo': {'id': 'ZS-2936'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with mesh exposure', 'description': 'During the physical examination, a speculum was inserted into the vagina to observe the vaginal epithelium for mesh exposure. If the mesh is seen on surface of the vaginal mucosa, the patient is diagnosed with mesh exposure.'}, {'label': 'Patients without mesh exposure', 'description': 'During the physical examination, a speculum was inserted into the vagina to observe the vaginal epithelium for mesh exposure. If the mesh is not seen on surface of the vaginal mucosa, bimanual examination will be performed to confirm no foreign body can be feeled on surface of the vaginal mucosa. Then the patient belong to this group.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhibo Zhang', 'role': 'CONTACT', 'email': 'zzbspace@126.com', 'phone': '13693317164'}, {'name': 'Lan Zhu', 'role': 'CONTACT', 'email': 'zhu_julie@vip.sina.com', 'phone': '13911714696'}], 'overallOfficials': [{'name': 'Lan Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}