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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03652025

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency	Procedure: embolotherapy of incompetent gonadal and iliac veins	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2018

Anticipated Primary Completion Date :

Apr 15, 2019

Anticipated Study Completion Date :

Jun 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group perimenopausal women	Procedure: embolotherapy of incompetent gonadal and iliac veins minimally invasive

Arm

Intervention/Treatment

Experimental: Study group

perimenopausal women

Procedure: embolotherapy of incompetent gonadal and iliac veins

minimally invasive

Outcome Measures

Primary Outcome Measures

The difference in pain score before and after therapy [one year]
validated analogue scoring of pain From 0 to 10 according to symptoms improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

endometriosis diverticulitis fasciitis psychosexual dysfunction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ahmadnaserhussein, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03652025

Other Study ID Numbers:

AssiutU777

First Posted:

Aug 29, 2018

Last Update Posted:

Aug 29, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Venous Insufficiency

Study Results

No Results Posted as of Aug 29, 2018