Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Quality of life, pain and fertility
研究概览
简要总结
The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.
详细描述
Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only).
A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed.
A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed.
Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •13-55 years of age
- •Anyone seen at the Center for Endometriosis
排除标准
- •Prior bilateral salpingo-oophorectomy
- •post natural menopause
- •Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.
结局指标
主要结局
Quality of life, pain and fertility
时间窗: every 12 months
(QOL) endometriosis health profile (EHP-5)
次要结局
未报告次要终点
研究者
Patrick Yeung Jr., MD
Principal Investigator
St. Louis University