Clinical trial NCT03568149: Pelvic Congestion Syndrome and Endometriosis
Official title: Ultrasound Evaluation of the Prevalence of Pelvic Congestion Syndrome in Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Congestive Syndrome
Endometriosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing routine gynecological examinations in our center are included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of pelvic congestive syndrome in patients with endometriosis
timeFrame: 1 day, first medical examination
Secondary outcomes:
measure: Correlation between type of pain and pelvic congestive syndrome
timeFrame: 1 day, first medical examination
measure: Correlation between pain severity and pelvic congestive syndrome
timeFrame: 1 day, first medical examination
measure: Correlation between symptoms and ongoing medical treatments
timeFrame: 1 day, first medical examination
measure: Correlation between history of pelvic surgery and pelvic congestive syndrome
timeFrame: 1 day, first medical examination
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
state: BO
Study officials:
References: