Endothelial Dysfunction Among Woman With Endometriosis

Endothelial Dysfunction Among Woman With Endometriosis After Surgical Treatment

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.

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Diagnostic test: • Endothelial function using ENDOPAT system

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: eyal rom, MD; Phone Number: 972546747434; Email: eyalro@clalit.org.il

Study Locations

• Israel
  • Afula, Israel
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endometriosis; Women who undergoing surgery for removal of endometriosis implants	Diagnostic test: • Endothelial function using ENDOPAT system; All of the participants will follow an non-invasive test for endothelial function using ENDOPAT 2000 device before surgery. A consecutive assessment will be held 6 weeks and 2 years post-surgery, using the same method.
Active Comparator: non-endometriosis; Women who undergoing surgery for removal of benign masses in the pelvis	Diagnostic test: • Endothelial function using ENDOPAT system; All of the participants will follow an non-invasive test for endothelial function using ENDOPAT 2000 device before surgery. A consecutive assessment will be held 6 weeks and 2 years post-surgery, using the same method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline endothelial function at 6 weeks	RHI index - "Reactive Hyperemia Index"	before and 6 weeks after surgery
Change from baseline inflammatory markers at 6 weeks	C-reactive protein	before and 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline pain score at 6 weeks	visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). a lower pain level 6 weeks after surgery is a better outcome	before and 6 weeks after surgery
Change from baseline quality of life score at 6 weeks	The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. a higher score 6 weeks after surgery is a better outcome	before and 6 weeks after surgery

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: eyal rom, MD, HaEmek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 7, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 0100-18-emc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes