Effect of Lugol's Solution in the Patients With Graves' Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 5, 2007

Last Updated Date

October 17, 2008

Start Date ^†

September 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00432146 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Effect of Lugol's Solution in the Patients With Graves' Disease

Official Title ^†

Positive Effect of Lugol's Solution on the Blood Flow and Microvessel Density of Thyroid Gland in the Patients With Graves' Disease

Brief Summary

Context: Although some of endocrine surgeons administer Lugol's solution to decrease thyroid gland vascularity, there is still no agreement on its effectiveness. Objective: The aims of this clinical trial are to evaluate thyroid blood flow and microvessel density in the patients with Graves' disease according to the Lugol's solution treatment preoperatively. Design: Retrospective clinical trial. Setting: A tertiary referral center. Method: Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it.

Main Outcome Measures: Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.

Detailed Description

Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it. Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.

Study Phase

Study Type ^†

Observational

Study Design ^†

Prospective

Condition ^†

Graves Disease

Intervention ^†

Drug: lugol's solution

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Graves disease

Exclusion Criteria:

Anticoagulant usage,
Previous thyroid operation,
Refused to participate in this study.

Gender

Both

Ages

14 Years to 61 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00432146

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Istanbul University

Collaborators ^††

Investigators ^†

Study Director:

yesim erbil

Istanbul University

Information Provided By

Istanbul University

Verification Date

February 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.