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Clinical Trial Summary

Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown. In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.


Clinical Trial Description

Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery. PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05043584
Study type Interventional
Source Regional Hospital West Jutland
Contact
Status Completed
Phase N/A
Start date September 15, 2021
Completion date December 1, 2023

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