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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pelvic Floor

Clinical Trial Details

NCT number	NCT03620565
Study type	Observational
Source	Peking Union Medical College Hospital
Contact	Shuo Liang, MD
Phone	+8613718879529
Email	leahleung@foxmail.com
Status	Recruiting
Phase
Start date	June 1, 2018
Completion date	December 2023

View Details

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