Clinical trial NCT04013126: Endothelial Dysfunction Among Woman With Endometriosis
Official title: Endothelial Dysfunction Among Woman With Endometriosis After Surgical Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometriosis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups (treatment, control) each group is evaluated pre and post-surgery
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

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, so no difference was shown between them and healthy women, 2 years thereafter.

In a large meta-analysis, evaluating 5,547 patients, every 1% improvement in the FMD scale resulted in a 13% decrease in the rate of cardio-vascular events.

In a meta-analysis evaluating 5,547 patients a 13% reduction in the risk to cardio-vascular events was demonstrated for every 1% improvement in the FMD score.

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.

Eligibility criteria: Inclusion Criteria:

* Women who undergoing surgery for removal of endometriosis implants

Exclusion Criteria:

* 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)
* Smoking
* Pregnant women or gave birth in the past 3 months

Primary outcomes:
measure: Change from baseline endothelial function at 6 weeks
timeFrame: before and 6 weeks after surgery
measure: Change from baseline inflammatory markers at 6 weeks
timeFrame: before and 6 weeks after surgery
Secondary outcomes:
measure: Change from baseline pain score at 6 weeks
timeFrame: before and 6 weeks after surgery
measure: Change from baseline quality of life score at 6 weeks
timeFrame: before and 6 weeks after surgery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: Eyal Rom, MD
role: PRINCIPAL_INVESTIGATOR
References: