Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
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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 |
- 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 |
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 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 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013