Ultrasound Evaluation of the Prevalence of Pelvic Congestion Syndrome in Patients With Endometriosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pelvic Congestive Syndrome
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Incidence of pelvic congestive syndrome in patients with endometriosis
- Last Updated
- 6 years ago
Overview
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.
Investigators
Mohamed Mabrouk
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Menopause
- •Actual or previous pregnancy
Outcomes
Primary Outcomes
Incidence of pelvic congestive syndrome in patients with endometriosis
Time Frame: 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 Outcomes
- 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 type of pain and pelvic congestive syndrome(1 day, first medical examination)
- Correlation between history of pelvic surgery and pelvic congestive syndrome(1 day, first medical examination)