Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

Not yet recruiting

• Conditions: Vaginal Microbiome; Graft Versus Host Reaction

• Registration Number: NCT05000112
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-27
• Primary Completion: 2023-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal microbiome-host Interaction associated with mesh exposure after TVM	Over 6 months postoperative
Vaginal microbiome-host interaction in patients after TVM	Over 6 months postoperative

Secondary Outcome Measures

Name	Time	Method
Difference of vaginal microbiome between groups	Over 6 months postoperative
Differentially expressed genes in host-mesh interaction between groups	Over 6 months postoperative