NCT03620565

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 13,120 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the incidence and distribution of complications after different pelvic reconstruction surgeries using mesh/native tissue in multi-centers using the IUGA/ICS complication classification system(the Category-Time-Site(CTS) coding).

Detailed description

Patients who undergo different pelvic floor reconstructive surgeries for the cure of pelvic organ prolapse(POP)and/or stress urinary incontinence(SUI) between June 2018 and June 2023 from 27 tertiary hospitals are prospectively collected.Our study aims to follow-up and report the incidences of postoperative complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system).The aimed pelvic floor reconstructive surgeries involve anterior,apical, posterior or total pelvic reconstruction with trans-vaginal mesh,open/laparoscopic sacrocolpopexy(Y-tape/self-cut synthesized mesh),repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension,ischial spinous fascia fixation, the Lefort operation and so on)and as well as anti-urinary incontinence surgeries(tension-free vaginal tape). Our follow-up process start after patients have completed the operation,thus our study do not affect patients' choice of surgical method.

Conditions

• Pelvic Floor

Timeline

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

Locations

1 site across 1 country: China