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NCT03652025 Clinical Trial

The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities

Venous Insufficiency Clinical Trial

Official title:
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03652025
Other study ID # AssiutU777
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date June 15, 2019

Study information
Verified date August 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency .

chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem.

Description:

this study includes clinical and imaging and interventional aspects. detailed history and comprehensive examination of the patient. duplex ultrasonography to detect pelvic varices and presence of reflux. renal and left iliac venogram is usually the first step in the evaluation of compressive syndrome. then cannulate the gonadal and internal iliac veins selectively. contrast medium injected , the incompetent gonadal veins are generally dilated and the contrast pools in the pelvis after injection. embolization by injecting afoam sclerosant as distally as possible to occlude the pelvic venous plexus using occlusion balloon proximal.

follow up assessment by VAS score and duplex imaging.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 15, 2019
Est. primary completion date April 15, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- premenopausal women ovarian point tenderness post coital pain atypical lower limb varices

Exclusion Criteria:

- endometriosis diverticulitis fasciitis psychosexual dysfunction

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• embolotherapy of incompetent gonadal and iliac veins
minimally invasive

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary The difference in pain score before and after therapy validated analogue scoring of pain From 0 to 10 according to symptoms improvement one year
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