NCT03568149

Pelvic Congestion Syndrome and Endometriosis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pelvic Congestive Syndrome
• Endometriosis

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2018-12-14
• Primary completion: 2019-07-01
• Completion: 2019-08-01
• First posted: 2018-06-26
• Last updated: 2019-06-12

Locations

1 site across 1 country: Italy