NCT05000112尚未招募不适用
The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Vaginal microbiome-host Interaction associated with mesh exposure after TVM
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Have had sex in the past 5 days or had vaginal irrigation;
- •Use oral or vaginal antibiotics, antifungal, immunosuppressant, hormone drugs or probiotics for the last 30 days.
- •Combined with immunosuppressive diseases, diseases with contraindication of vaginal estrogen such as breast cancer, endometrial cancer.
- •If the patient has a uterus before surgery and does not undergo total transvaginal hysterectomy during surgery,
- •Intraoperative bladder injury or intraoperative hemorrhage >500ml or postoperative hematoma.
结局指标
主要结局
Vaginal microbiome-host Interaction associated with mesh exposure after TVM
时间窗: Over 6 months postoperative
Vaginal microbiome-host interaction in patients after TVM
时间窗: Over 6 months postoperative
次要结局
- Differentially expressed genes in host-mesh interaction between groups(Over 6 months postoperative)
- Difference of vaginal microbiome between groups(Over 6 months postoperative)
研究者
相似试验
已完成
不适用
The Clinical Outcome of TVM or LSC Mesh Suspension for POPPelvic Organ ProlapseNCT04139083Kaohsiung Medical University Chung-Ho Memorial Hospital466
已完成
不适用
Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for CholecystectomyCholecystectomyNCT01078025Cantonal Hospital of St. Gallen30
进行中（未招募）
不适用
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host DiseaseBone Marrow Transplant ComplicationsNCT05316740Hadassah Medical Organization40
已完成
不适用
Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study.Infertility, FemaleNCT05161338Instituto Valenciano de Infertilidad, IVI VALENCIA100
已完成
4 期
Modulating the Vaginal Microbiome After Implantation FailureImplantation FailureInfertility, FemaleVaginal Flora ImbalanceNCT03843112Zealand University Hospital74