Endothelial Dysfunction Among Woman With Endometriosis After Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline endothelial function at 6 weeks
研究概览
简要总结
Endometriosis is a chronic disease defined as an ectopic endometrial tissue outside the, and associated with chronic inflammatory state and increased risk of atherosclerosis.
Endothelial dysfunction plays an important and elementary role in the development of atherosclerosis.
There are number of non-invasive tests for evaluating the endothelial function. One of them is FMD - "Flow Mediated Dilatation". Clinical studies proved the efficacy of this method in predicting cardio-vascular events in patients with established heart disease and also as an independent risk factor, better than the traditional ones.
An alternative method, developed in recent years, is evaluation of peripheral blood vessels tone - "Peripheral Arterial Tonometry" - (PAT). It evaluates the pulsatile blood volume of the blood vessels in the fingertips during reactive hyperemia. The obtained value "reactive hyperemic index" (RHI) correlates well with FMD as well with coronary arteries endothelial dysfunction.
it well suited as a clinical tool or as a test for a large-scale clinical study.
Endothelial dysfunction has been demonstrated among woman with endometriosis. After surgical removal of endometrial implants there was a substantial improvement in the endothelial function, by imaging (using FMD) and by inflammatory markers
In this study the investigators will follow the endothelial function among women undergoing endometrial implants surgical removal, before and after the surgery, using PAT technology (ENDOPAT system). Inflammatory markers and quality of life parameters will also be evaluated.
The follow-up will include one meeting 6 weeks after the procedure The investigators expect an improvement in the endothelial function among women who had endometriosis implants removal.
详细描述
Endometriosis is a chronic disease defined as an ectopic endometrial tissue outside the uterus, mostly in the pelvis. It is related to major morbidity and infertility. It is also associated with chronic inflammatory state and increased risk of atherosclerosis.
Endothelial dysfunction plays an important and elementary role in the development of atherosclerosis.
There are number of non-invasive tests for evaluating the endothelial function. One of them is FMD - "Flow Mediated Dilatation". It refers to dilation (widening) of an artery when blood flow increases in that artery after An intentional block of the blood flow. Clinical studies proved the efficacy of this method in predicting cardio-vascular events in patients with established heart disease and also as an independent risk factor, better than the traditional ones.
An alternative method, developed in recent years, is evaluation of peripheral blood vessels tone - "Peripheral Arterial Tonometry" - (PAT). It evaluates the pulsatile blood volume of the blood vessels in the fingertips during reactive hyperemia. The obtained value "reactive hyperemic index" (RHI) correlates well with FMD as well with coronary arteries endothelial dysfunction.
The test is performed by attaching two sensors to the patient's fingertips. Using this method requires short training interval, completely user-independent and the accepted result is a quantitive index. Because it takes only 15 minute to complete the test it well suited as a clinical tool or as a test for a large-scale clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who undergoing surgery for removal of endometriosis implants
排除标准
- •Women under 18 or above 60 years of age
- •Women with known vascular disease
- •Women with chronic disease which effect the endothelial function (Diabetes mellitus, Hypertension, Obesity (Defined as BMI≥30), Atherosclerosis, Kidney disease, Collagen disease, Chronic inflammatory disease, and Etc.
- •History of Cardio-vascular event or venous thromboembolism (VTE)
- •Pregnant women or gave birth in the past 3 months
结局指标
主要结局
Change from baseline endothelial function at 6 weeks
时间窗: before and 6 weeks after surgery
RHI index - "Reactive Hyperemia Index"
Change from baseline inflammatory markers at 6 weeks
时间窗: before and 6 weeks after surgery
C-reactive protein
次要结局
- Change from baseline quality of life score at 6 weeks(before and 6 weeks after surgery)
- Change from baseline pain score at 6 weeks(before and 6 weeks after surgery)
研究者
Eyal Rom, MD
Principal Investigator
HaEmek Medical Center, Israel