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OpenTrials
Completed

NCT Number: NCT00946296

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UMASS Memorial Health Care

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potassium Iodide

Drug

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 names: SSKI

Primary outcomes

  1. Blood Loss During Surgery

    Time frame: up to 162 minutes

    Blood loss in milliliters during surgery.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2009
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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