Endometriosis, Pelvic Congestive Syndrome
Conditions
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.
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.
Interventions
PROCEDUREassessment 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.
PROCEDUREassessment 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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pelvic congestive syndrome in patients with endometriosis | 1 day, first medical examination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between type of pain and pelvic congestive syndrome | 1 day, first medical examination | Evaluation of the type of pain (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) presented by patients with pelvic congestive syndrome. |
| Correlation between pain severity and pelvic congestive syndrome | 1 day, first medical examination | 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). |
| Correlation between symptoms and ongoing medical treatments | 1 day, first medical examination | Evaluation of a possible correlation between symptoms and ongoing medical treatments in patients with pelvic congestive syndrome |
| Correlation between history of pelvic surgery and pelvic congestive syndrome | 1 day, first medical examination | Evaluation of a possible correlation between history of pelvic surgery and the presence of pelvic congestive syndrome |
Countries
Italy
Contacts
Primary ContactDiego Raimondo
Outcome results
None listed