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

August 27, 2018 updated by: ahmadnaserhussein, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis diverticulitis fasciitis psychosexual dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in pain score before and after therapy
Time Frame: one year
validated analogue scoring of pain From 0 to 10 according to symptoms improvement
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 15, 2018

Primary Completion (ANTICIPATED)

April 15, 2019

Study Completion (ANTICIPATED)

June 15, 2019

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU777

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe