Exploring Pre-operative Prediction of Pelvic Endometriosis, the Local Inflammatory Environment and Response to Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Endometriosis predictive model
研究概览
简要总结
The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of inflammation in enhancing this diagnosis.
The main questions it aims to answer are:
Can a non-invasive quantitative algorithm ('Endometriosis Diagnostic Index') accurately predict the presence or absence of pelvic endometriosis? Is the peripheral inflammatory environment (for example, presence of inflammatory cytokines and chemokine) different between people with and without endometriosis?
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consecutive female patients age 18-50 undergoing laparoscopy with the suspicion of endometriosis (as indicated by any recording in secondary care medical notes of endometriosis being a possible finding at laparoscopy; all those undergoing laparoscopy for sub-fertility (no conception after ≥6 months of trying, excluding confirmed male factor); or pelvic pain symptoms (dysmenorrhea; non-cyclical pelvic pain; dyspareunia; dyschezia) who is not otherwise excluded.
排除标准
- •previous surgically confirmed endometriosis;
- •postmenopausal status;
- •laparoscopy for acute indication (ectopic; tubo-ovarian abscess; adnexal torsion);
- •suspicion of malignancy;
- •the sole indication of tubal sterilisation;
- •the sole indication of myomectomy;
- •pregnant or breastfeeding;
- •significant medical co-morbidities including HIV and/or hepatitis B or C infection;
- •where gynaecology is not the primary team undertaking surgery;
- •unable to have transvaginal ultrasound (TVUSS);
- •declines to take part in the study;
- •patient unable to understand verbal or written information in English;
- •lack of capacity to consent at the point of recruitment;
- •known safeguarding issues.
结局指标
主要结局
Endometriosis predictive model
时间窗: 24 months
Multiple logistic regression model of predictive variables
次要结局
- Markers of inflammation(24 months)