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

U

University of Massachusetts, Worcester

Status and phase

Completed
Phase 4

Conditions

Hyperthyroidism
Graves Disease

Treatments

Drug: Potassium Iodide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Potassium Iodide
Active Comparator group
Description:
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Treatment:
Drug: Potassium Iodide
No Treatment
No Intervention group
Description:
The experimental group receives no treatment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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