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Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946296
First Posted: July 24, 2009
Last Update Posted: December 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Massachusetts, Worcester
  Purpose
The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.

Condition Intervention Phase
Graves Disease Hyperthyroidism Drug: Potassium Iodide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Blood Loss During Surgery [ Time Frame: up to 162 minutes ]
    Blood loss in milliliters during surgery.


Enrollment: 36
Study Start Date: April 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Potassium Iodide
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Drug: Potassium Iodide
8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
Other Name: SSKI
No Intervention: No Treatment
The experimental group receives no treatment.

Detailed Description:

Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss.

The outcomes to be measured in this surgery are operative time, operative complications and blood loss.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with a clinical diagnosis of Graves Disease
  • Patients who have selected surgical resection as treatment of their Graves Disease
  • Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid

Exclusion Criteria:

  • Patients deemed unfit for surgery by operating surgeon or anesthesist
  • Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946296


Locations
United States, Massachusetts
UMASS Memorial Health Care
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
  More Information

Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00946296     History of Changes
Other Study ID Numbers: 11597
First Submitted: July 22, 2009
First Posted: July 24, 2009
Results First Submitted: October 9, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015
Last Verified: November 2015

Keywords provided by University of Massachusetts, Worcester:
Graves Disease

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs