Hypocalcemia Clinical Trial
Official title:
Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia. A Randomized Controlled Trial
This Multicenter, Randomized Controlled Trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND) with NIR vs without NIR use during surgery.
Total thyroidectomy (TT) is responsible for postoperative hypocalcemia in 20-30% of patients,
which is definitive in 1-4% of operated patients (1). This complication is mainly due to
surgery-induced parathyroid dysfunction, which could be improved by a better intraoperative
identification of the parathyroids. Intraoperative parathyroid auto-fluorescence
visualization (without any dye injection) using near infrared light (NIR) is an emerging
technique, which allows correct identification of normal parathyroids in almost all cases
(2), but the clinical impact of NIR is unknown.
The aim of this prospective, comparative randomized study, is to compare 2 groups of
patients: patients operated with NIR (NIR+) vs patients operated without NIR (NIR-).
The main objective of this study is to assess the impact of intraoperative use of NIR camera
on postoperative hypocalcemia. Secondary objectives are to assess the impact of NIR on the
visualization, autotransplantation and inadvertent resection rates during TT.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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