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

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified August 2024 by Columbia University
Sponsor
Columbia University
Information Provided by (Responsible Party)
Jennifer Kuo
Clinicaltrials.gov Identifier
NCT04080505
Other Study ID Numbers:
AAAO3312
First Submitted
September 3, 2019
First Posted
September 5, 2019
Results First Posted
August 7, 2024
Last Update Posted
September 18, 2024
Last Verified
August 2024

ClinicalTrials.gov processed this data on September 2024Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Graves Disease
Drug: SSKI- Potassium Iodide

Study Design

Study TypeInterventional
Actual Enrollment29 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeOther
Official TitleDoes the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?
Study Start DateFebruary 9, 2015
Actual Primary Completion DateMarch 2, 2023
Actual Study Completion DateMarch 2, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
SSKI (Potassium Iodide)
Participants randomized to receive 7 days of pre-operative SSKI
Drug: SSKI- Potassium Iodide
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

Outcome Measures

Primary Outcome Measures
  1. Change in Vascular Flow From Baseline
    Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.
Exclusion Criteria
no Graves' disease
\< 18 years old

Contacts and Locations

Sponsors and CollaboratorsColumbia University
Locations
Columbia University Irving Medical Center | New York New York, United States, 10032
Investigators
Principal Investigator: Jennifer Kuo, MD, Columbia University
Study Documents (Full Text)
Documents provided by Columbia UniversityStudy Protocol and Statistical Analysis Plan  February 22, 2015