Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

NCT ID: NCT05000112

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-09-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lan Zhu

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Central Contacts

Zhibo Zhang

Role: CONTACT

zzbspace@126.com

13693317164

Lan Zhu

Role: CONTACT

zhu_julie@vip.sina.com

13911714696

Other Identifiers

ZS-2936

Identifier Type: -

Identifier Source: org_study_id