Pelvic Congestion Syndrome and Endometriosis

NCT03568149 | Unknown

• 1 other identifier: VES Study
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Congestive Syndrome; Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between type of pain and pelvic congestive syndrome

  1 day, first medical examination

• Correlation between pain severity and pelvic congestive syndrome

  1 day, first medical examination

• Correlation between symptoms and ongoing medical treatments

  1 day, first medical examination

• Correlation between history of pelvic surgery and pelvic congestive syndrome

  1 day, first medical examination

Study Arms (2)

Group A: endometriosis

assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.

Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs

Group B: no endometriosis

assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.

Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs

Interventions

assessment of pain symptoms at first medical examination PROCEDURE

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.

Group A: endometriosis; Group B: no endometriosis

assessment of pelvic vascular insufficiency signs PROCEDURE

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.

Group A: endometriosis; Group B: no endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing routine gynecological examinations in our center are included in the study.

You may qualify if:

• Obtaining Informed Consent
• Nulliparity
• Clinical or ultrasounds signs of endometriosis
• Obtaining Informed Consent
• Nulliparity

You may not qualify if:

• Menopause
• Actual or previous pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Diego Raimondo

CONTACT

00390512144385; die.raimondo@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 26, 2018
• Study Start: December 14, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)