NCT03617211

The Follow-up of Mesh/Native Tissue Complications Study(Part II)

A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part II).

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,530 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International Urogynecological AssociationInternational Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system) .

Detailed description

Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. And the date of surgeries carried is not restricted in the study period. This is a study of real world. The researchers focus to investigate the incidence of complications in clinical practice.

Conditions

• Pelvic Organ Prolapse

Timeline

• Start date: 2018-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2018-08-06
• Last updated: 2018-08-06

Locations

5 sites across 1 country: China