A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part II).
试验速览
- 阶段
- 不适用
- 入组人数
- 1,530
- 试验地点
- 5
- 主要终点
- The frequency and ratio of different postoperative complications
研究概览
简要总结
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) .
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
- •Pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
- •Both primary and repeated pelvic surgery are included.
排除标准
- •If the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for "the same code complication in other 26 hospitals, she will be ruled out.
结局指标
主要结局
The frequency and ratio of different postoperative complications
时间窗: 1-year;3-year;5-year
Calculate the frequency(reported in number of cases) and ratio(reported in percentage, %) of different complications reported from 27 tertiary hospitals in the past year or 3 years or 5 years, respectively.The complications occurred after pelvic reconstructive surgeries, especially mesh/native tissue related,are classified by IUGA-ICS CTS(category-time-site)coding system.
次要结局
- The distribution of complications after each kind of pelvic reconstructive surgery(1-year;3-year;5-year)
- The percentage of various pelvic reconstructive surgeries under the same complication classification coding.(1-year;3-year;5-year)