Hypocalcemia Clinical Trial
Official title:
Parathyroid Autofluorescence Visualization During Thyroid Surgery: Impact on Postoperative Hypocalcemia
This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid
autofluorescence visualization using near infrared light (NIR) during total thyroidectomy
(TT).
It compares two groups of consecutive patients who underwent TT associated or not to lymph
node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.
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 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.
The investigators compare 2 groups of patients operated by one surgeon during 2 consecutive
but distinct periods (before and after the use of NIR) with control groups operated by
another surgeon during the same periods. This study is observational since there was no
predefined protocol nor sample size calculation of study groups prior to data collection.
;
Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02892253 -
Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia
|
N/A | |
| Completed |
NCT05043584 -
Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions
|
N/A | |
| Recruiting |
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|
||
| Recruiting |
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||
| Completed |
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N/A | |
| Recruiting |
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Registry for Hypoparathyroidism Wuerzburg
|
||
| Recruiting |
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|
Phase 4 | |
| Recruiting |
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|
N/A | |
| Completed |
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Phase 2 | |
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| Terminated |
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Phase 2 | |
| Completed |
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|
Phase 2 | |
| Not yet recruiting |
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||
| Terminated |
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Phase 2 | |
| Completed |
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Phase 3 | |
| Not yet recruiting |
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Phase 4 | |
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Phase 3 | |
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|
Phase 4 |