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Endothelial Dysfunction Among Woman With Endometriosis

Primary Purpose

Endometriosis

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
• Endothelial function using ENDOPAT system
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Haemek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endometriosis

non-endometriosis

Arm Description

Women who undergoing surgery for removal of endometriosis implants

Women who undergoing surgery for removal of benign masses in the pelvis

Outcomes

Primary Outcome Measures

Change from baseline endothelial function at 6 weeks
RHI index - "Reactive Hyperemia Index"
Change from baseline inflammatory markers at 6 weeks
C-reactive protein

Secondary Outcome Measures

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
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

Full Information

First Posted
July 4, 2019
Last Updated
September 20, 2023
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT04013126
Brief Title
Endothelial Dysfunction Among Woman With Endometriosis
Official Title
Endothelial Dysfunction Among Woman With Endometriosis After Surgical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment rate
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
September 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups (treatment, control) each group is evaluated pre and post-surgery
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endometriosis
Arm Type
Experimental
Arm Description
Women who undergoing surgery for removal of endometriosis implants
Arm Title
non-endometriosis
Arm Type
Active Comparator
Arm Description
Women who undergoing surgery for removal of benign masses in the pelvis
Intervention Type
Diagnostic Test
Intervention Name(s)
• Endothelial function using ENDOPAT system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline endothelial function at 6 weeks
Description
RHI index - "Reactive Hyperemia Index"
Time Frame
before and 6 weeks after surgery
Title
Change from baseline inflammatory markers at 6 weeks
Description
C-reactive protein
Time Frame
before and 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Change from baseline pain score at 6 weeks
Description
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
Time Frame
before and 6 weeks after surgery
Title
Change from baseline quality of life score at 6 weeks
Description
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
Time Frame
before and 6 weeks after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Rom, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel

12. IPD Sharing Statement

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Endothelial Dysfunction Among Woman With Endometriosis

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