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

NCT ID: NCT00946296

Last Updated: 2015-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Graves Disease Hyperthyroidism

Keywords

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Graves Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Potassium Iodide

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

Group Type ACTIVE_COMPARATOR

Potassium Iodide

Intervention Type 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.

No Treatment

The experimental group receives no treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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SSKI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UMASS Memorial Health Care

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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11597

Identifier Type: -

Identifier Source: org_study_id