Vaginal Microbiome Clinical Trial
Official title:
The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2024 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 1. Have had sex in the past 5 days or had vaginal irrigation; - 2. Use oral or vaginal antibiotics, antifungal, immunosuppressant, hormone drugs or probiotics for the last 30 days. - 3. Combined with immunosuppressive diseases, diseases with contraindication of vaginal estrogen such as breast cancer, endometrial cancer. - 4. If the patient has a uterus before surgery and does not undergo total transvaginal hysterectomy during surgery, - 5. Intraoperative bladder injury or intraoperative hemorrhage >500ml or postoperative hematoma. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Peking Union Medical College Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal microbiome-host interaction in patients after TVM | Over 6 months postoperative | ||
Primary | Vaginal microbiome-host Interaction associated with mesh exposure after TVM | Over 6 months postoperative | ||
Secondary | Difference of vaginal microbiome between groups | Over 6 months postoperative | ||
Secondary | Differentially expressed genes in host-mesh interaction between groups | Over 6 months postoperative |
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