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

Phase 4

Completed

• Conditions: Graves Disease; Hyperthyroidism
• Interventions: Drug: Potassium Iodide

• Registration Number: NCT00946296
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2015-10-09
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Results First Posted: 2015-12-15
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Potassium Iodide	Potassium Iodide	8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.

Primary Outcome Measures

Name	Time	Method
Blood Loss During Surgery	up to 162 minutes	Blood loss in milliliters during surgery.

Trial Locations

Locations (1)

UMASS Memorial Health Care; 🇺🇸 Worcester, Massachusetts, United States