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

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00432146
First received: February 5, 2007
Last updated: October 17, 2008
Last verified: February 2007
  Purpose

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.


Condition Intervention
Graves Disease
Drug: lugol's solution

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Positive Effect of Lugol's Solution on the Blood Flow and Microvessel Density of Thyroid Gland in the Patients With Graves' Disease

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Estimated Enrollment: 36
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   14 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Graves disease

Exclusion Criteria:

  • Anticoagulant usage,
  • Previous thyroid operation,
  • Refused to participate in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432146

Sponsors and Collaborators
Istanbul University
Investigators
Study Director: yesim erbil Istanbul University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00432146     History of Changes
Other Study ID Numbers: 2005/117
Study First Received: February 5, 2007
Last Updated: October 17, 2008
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
Graves' disease, Lugol's solution

Additional relevant MeSH terms:
Graves Disease
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases
Goiter
Hyperthyroidism
Immune System Diseases
Orbital Diseases
Thyroid Diseases
Lugol's solution
Pharmaceutical Solutions
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014