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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05000112
Other study ID # ZS-2936
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date September 2024

Study information

Verified date July 2021
Source Peking Union Medical College Hospital
Contact Zhibo Zhang
Phone 13693317164
Email zzbspace@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Outcome

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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