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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium Iodide | Active Comparator | 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. |
|
| No Treatment | No Intervention | The experimental group receives no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss During Surgery | Blood loss in milliliters during surgery. | up to 162 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMASS Memorial Health Care | Worcester | Massachusetts | 01655 | United States |
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Between October 2005 and April 2013, subjects who had been determined to undergo thyroidectomy for definitive management of Graves Disease, were approached for participation in the study. Recruitment occurred in the endocrine practices of the investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Potassium Iodide | 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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. |
| FG001 | No Treatment | The experimental group receives no treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Potassium Iodide | 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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. |
| BG001 | No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Loss During Surgery | Blood loss in milliliters during surgery. | Posted | Mean | Standard Deviation | mL | up to 162 minutes |
|
162 minutes
During surgical procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Potassium Iodide | 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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. |
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Difficulty in enrolling subjects related to national shortages of potassium iodine which limited drug availability and contributed to delayed accrual as did decreased eligible patients and waning interest over time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Giles Whalen | UMass Medical School | 508-334-5202 | Giles.Whalen@umassmemorial.org |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| ID | Term |
|---|---|
| D011193 | Potassium Iodide |
| ID | Term |
|---|---|
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
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|
The experimental group receives no treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | No Treatment | The experimental group receives no treatment. | 0 | 15 | 0 | 15 |
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| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |