Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04080505|
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Graves Disease||Drug: SSKI- Potassium Iodide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
|Masking:||None (Open Label)|
|Official Title:||Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?|
|Actual Study Start Date :||February 10, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: 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 Intervention: NO SSKI
Participants randomized to not receive any drug pre-operative
- Change in Vascular Flow from Baseline [ Time Frame: From Baseline to Immediately Before Surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080505
|Contact: Jennifer Kuo, MDemail@example.com|
|Contact: Vilma Rosariofirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Jennifer Kuo, MD 212-305-6969 email@example.com|
|Contact: Vilma Rosario 212-305-6033 firstname.lastname@example.org|
|Principal Investigator: Jennifer Kuo, MD|
|Principal Investigator:||Jennifer Kuo, MD||Columbia University Irving Medical Center|