Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?

NCT ID: NCT04080505

Last Updated: 2024-09-19

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-10

Study Completion Date

2023-03-03

Brief Summary

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The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).

Detailed Description

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Patients with Graves' disease and goiters tend to have very vascular thyroid glands, which increases operative bleeding risks/rates. Many surgeons treat these patients with preoperative SSKI which is believed to decrease the vascularity, which in turn may decrease bleeding risks. However, there has been no quantitative data published on whether this is a real effect with true clinical benefit, in either animal or human models with SSKI. There have been some studies in Europe studying Lugol's solution, a different formulation of iodine, which show some decreased vascularity using color Doppler or measurements of CD34 cells.

Conditions

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Graves Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All participants complete a baseline neck ultrasound no less than 7 days prior to surgery, to obtain vascular flow imaging. Participants are then randomized to receive 7 days of pre-operative SSKI or not receive any drug. In the practice at Columbia, all patients with Graves' disease receive SSKI preoperatively, though this is not standard practice across the country, thus the 'no drug' group is experimental for research.

All participants complete a second ultrasound on the operating table before surgery, to assess for change in vascularity (experimental, as not all patients receive intra-operative ultrasounds before surgery). Both ultrasounds are performed by the surgeon.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SSKI (Potassium Iodide)

Participants randomized to receive 7 days of pre-operative SSKI

Group Type ACTIVE_COMPARATOR

SSKI- Potassium Iodide

Intervention Type DRUG

1g/mL, 2 drops orally 3 times a day for 7 days before surgery

NO SSKI

Participants randomized to not receive any drug pre-operative

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SSKI- Potassium Iodide

1g/mL, 2 drops orally 3 times a day for 7 days before surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.

Exclusion Criteria

* no Graves' disease
* \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Kuo

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AAAO3312

Identifier Type: -

Identifier Source: org_study_id

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