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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Giles Whalen, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00946296
First received: July 22, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine whether a brief course of SSKI (iodine) 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 Iodine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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: Post Operatively ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: April 2005
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Receives Potassium Iodine which is the current Standard of Care
Drug: Potassium Iodine
8 drops of Potassium Iodine in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. The Experimental Group is the group which receives no Potassium Iodine.
Experimental: No Treatment Drug: Potassium Iodine
8 drops of Potassium Iodine in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. The Experimental Group is the group which receives no Potassium Iodine.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00946296

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

No publications provided

Responsible Party: Giles Whalen, Professor of Surgery, University of Massachusetts Medical School, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00946296     History of Changes
Other Study ID Numbers: 11597
Study First Received: July 22, 2009
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Graves Disease

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases
Goiter
Immune System Diseases
Orbital Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on October 20, 2014