Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05000112

Enrollment

Registered

2021-08-11

Start date

2021-09-30

Completion date

2024-09-30

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Reaction, Vaginal Microbiome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactZhibo Zhang

zzbspace@126.com13693317164

Backup ContactLan Zhu

zhu_julie@vip.sina.com13911714696

Outcome results