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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03943381
Other study ID # Duplex US in PCS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 10, 2019
Est. completion date October 2019

Study information

Verified date April 2019
Source Assiut University
Contact Mohamed A Sayed
Phone +201008253457
Email dr.abudeif@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome


Description:

- In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.

- Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date October 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria:

- All patients with signs and symptoms of PCS

Exclusion Criteria:

- No

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Duplex US
Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Duplex US in Pelvic Congestion Syndrome in females to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome 6 months
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