Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

NCT05000112 | Unknown

• 1 other identifier: ZS-2936
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaginal Microbiome; Graft Versus Host Reaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Difference of vaginal microbiome between groups

  Over 6 months postoperative

• Differentially expressed genes in host-mesh interaction between groups

  Over 6 months postoperative

Study Arms (2)

Patients with mesh exposure

During the physical examination, a speculum was inserted into the vagina to observe the vaginal epithelium for mesh exposure. If the mesh is seen on surface of the vaginal mucosa, the patient is diagnosed with mesh exposure.

Patients without mesh exposure

During the physical examination, a speculum was inserted into the vagina to observe the vaginal epithelium for mesh exposure. If the mesh is not seen on surface of the vaginal mucosa, bimanual examination will be performed to confirm no foreign body can be feeled on surface of the vaginal mucosa. Then the patient belong to this group.

Eligibility Criteria

• Age: 45 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Officials

• Lan Zhu

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhibo Zhang

CONTACT

13693317164; zzbspace@126.com

Lan Zhu

CONTACT

13911714696; zhu_julie@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: September 27, 2021

Record last verified: 2021-07