Pelvic Congestion Syndrome and Endometriosis

Endometriosis Clinical Trial

— VES  

Official title:

Ultrasound Evaluation of the Prevalence of Pelvic Congestion Syndrome in Patients With Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568149
• Other study ID #: VES Study
• Status: Recruiting
• Start date: December 14, 2018
• Est. completion date: August 2019

Study information

• Verified date: June 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Diego Raimondo
• Phone: 00390512144385
• Email: die.raimondo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The pelvic congestion syndrome (PCS) is a complex and multifactorial condition associated with inflammatory and hormonal etiophatogenesis similar to the endometriosis.

Furthermore, both pathologies share same clinical symptoms as chronic pelvic pain and dyspareunia.

Our hypothesis is that PCS prevalence is higher in patients with endometriosis than in those without clinical or ultrasound signs of endometriosis.

Description:

Patients undergoing routine gynecological examinations are included in the study.

Patients are divided into 2 groups:

• Group A: with endometriosis

• Group B: without clinical or ultrasound signs of endometriosis This is an observational, monocentric, prospective, exploratory study. The aim is to assess PCS incidence, associated symptoms and ultrasound characteristics in patients with endometriosis and to compare those findings to those of patients who do not present clinical or ultrasound signs of endometriosis.

The study also evaluates the correlation between:

• Type of pain symptoms (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) and PCS

• Pain severity (assessed according to VAS scale from 0= no pain to 10= unbearable pain) and PCS

• Symptoms and ongoing medical treatments

• History of pelvic surgery and PCS.

Ultrasound parameters of pelvic vascular insufficiency are:

• Ovarian vein diameter <4mm

• Slow ovarian blood flow (<3cm/sec)

• Retrograde blood flow

• Dilated arcuate veins communicating with pelvic varices

• The presence of pelvic varices is evaluated qualitatively as normal, moderate and serious

This evaluation includes the study of uterine and ovarian vessels, using different techniques:

• Standard 2D study: it allows to measure vessels diameter

• Vascular doppler study: it allows to evaluate flow direction and blood speed

• 3D color study: it allows a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.

• Ultrasound images are evaluated independently by two operators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria (Group A):

• Obtaining Informed Consent

• Nulliparity

• Clinical or ultrasounds signs of endometriosis

Inclusion Criteria (Group B):

• Obtaining Informed Consent

• Nulliparity

Exclusion Criteria:

• Menopause

• Actual or previous pregnancy

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Congestive Syndrome
• Syndrome

Intervention

Procedure:
• assessment of pain symptoms at first medical examination
First medical examination consists of collection of medical history and standard gynecological examination (bimanual gynecological examination and abdominopelvic ultrasounds). Data regarding age, Body Mass Index, ongoing hormone therapy and pelvic pain symptoms, assessed according to Visual Analogue Scale (VAS) (from 0= no pain to 10= unbearable pain), are collected. The presence of perineal or lower limb varices and the presence and localization of evoked pain at bimanual gynecological examination are also evaluated.
• assessment of pelvic vascular insufficiency signs
Assessment of pelvic vascular insufficiency in conducted using abdominopelvic ultrasounds, according to the following parameters: Ovarian vein diameter <4mm Slow ovarian blood flow (<3cm/sec) Retrograde blood flow Dilated arcuate veins communicating with pelvic varices The presence of pelvic varices is evaluated qualitatively as normal, moderate and serious This evaluation includes the study of uterine and ovarian vessels, using different techniques: Standard 2D study, to measure vessels diameter Vascular doppler study, to evaluate flow direction and blood speed 3D color study, for a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.

Locations

Country	Name	City	State
Italy	Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pelvic congestive syndrome in patients with endometriosis	Comparison of pelvic congestive syndrome symptoms and ultrasounds characteristics, assessed by standard gynecological examination (bimanual gynecological examination and gynecological ultrasounds), between patients with endometriosis (Group A) and without clinical or ultrasound signs of endometriosis.	1 day, first medical examination
Secondary	Correlation between type of pain and pelvic congestive syndrome	Evaluation of the type of pain (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) presented by patients with pelvic congestive syndrome.	1 day, first medical examination
Secondary	Correlation between pain severity and pelvic congestive syndrome	Evaluation of a possible correlation between pain severity and the presence of pelvic congestive syndrome. Pain severity is assessed according to Visual Analogue Scale (VAS scale from 0= no pain to 10= unbearable pain).	1 day, first medical examination
Secondary	Correlation between symptoms and ongoing medical treatments	Evaluation of a possible correlation between symptoms and ongoing medical treatments in patients with pelvic congestive syndrome	1 day, first medical examination
Secondary	Correlation between history of pelvic surgery and pelvic congestive syndrome	Evaluation of a possible correlation between history of pelvic surgery and the presence of pelvic congestive syndrome	1 day, first medical examination