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Pelvic Congestion Syndrome and Endometriosis

NCT03568149 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2019-06-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2019-07-31
Completion
2019-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568149 on ClinicalTrials.gov