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A study of the mechanism of occurrence of perivascular cell proliferation leading to mesh exposure in pelvic floor reconstruction surgery

A study of the mechanism of occurrence of perivascular cell proliferation leading to mesh exposure in pelvic floor reconstruction surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086953
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-07-30
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

pelvic organ prolapse

Interventions

experimental group:None
control group:None

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Previous pelvic floor reconstruction with mesh and >1 year from the last pelvic floor reconstruction with mesh procedure; (2) Enrollment criteria for the test group: patients in the test group were required to have a clinical diagnosis of mesh exposure, with mesh exposure defined as mesh visible through the vaginal epithelium for at least 2 mm. The mesh in all subjects must be a mesh implanted from the anterior pelvic/vaginal apex. Inclusion criteria for the control group: patients in the control group did not have mesh exposure, did not meet the diagnosis of mesh exposure, patients were admitted to the hospital for other pelvic floor disorders with a proposed plan for surgical removal of all/part of the mesh, and the primary surgical indication was other pelvic floor disorders such as urinary incontinence and post hysterectomy vault prolapse. All subjects must have mesh implanted from the anterior pelvic/vaginal apex. (3) Voluntary enrollment in the study with signed informed consent; (4) Age range of 40-80 years.

Exclusion criteria

Exclusion criteria: (1) Severe medical comorbidities that preclude tolerating surgery; (2) Bowel or bladder erosion of the mesh; (3) Acute episodes of inflammation, such as fever, vaginal wall abscesses, and vaginal ulcers; (4) Patients undergoing chronic immunosuppressive therapy or suffering from autoimmune diseases; (5) The presence of malignant lesions of the vagina, cervix, or endometrium.

Design outcomes

Primary

MeasureTime frame
PDGFRß;

Secondary

MeasureTime frame
CD31;Notch3;a-SMA;

Countries

China

Contacts

Public ContactXin Yang

Department of Gynaecology, Peking University People's Hospital

xinyang_2003@sina.com+86 178 8880 9927

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026