Clinical trial NCT05000112: Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery
Official title: The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Microbiome
Graft Versus Host Reaction
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: