A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,147
- 试验地点
- 1
- 主要终点
- The incidence rate of complications
研究概览
简要总结
This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).
详细描述
Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are going to be prospectively collected. The study is designed to report the clinical data，outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.
The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.
排除标准
- •Currently pregnant at enrollment;
- •Physically or mentally unable to participate in up to 36 months of follow-up;
- •Desires other surgical management of POP other than trans-vaginal mesh.
结局指标
主要结局
The incidence rate of complications
时间窗: 36 months postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
次要结局
- Change from preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up(Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively)
- Changes in sexual function and measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire（PISQ-12）scores(Preoperatively; At 1 year and 3 year postoperatively)
- Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh(6 weeks, 3 months and each year, up to 3-year postoperatively)
- Patient global impression of improvement (PGI-I)(At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively)
- Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores(Preoperatively; At 1 year and 3 year postoperatively)
- Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores(Preoperatively; At 1 year and 3 year postoperatively)
研究者
zhulan
MD, the Chief of General Gynecology Center, the Department of Obstetrics & Gynecology
Peking Union Medical College Hospital