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In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.
For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence in thyroid surgery | Experimental | Patients undergoing thyroid surgery with cervical fluorescence. |
|
| No Fluorescence in thyroid surgery | No Intervention | patients undergoing thyroid surgery without cervical fluorescence. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence in thyroid surgery | Procedure | Fluorescence in thyroid surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type of surgery performed | total thyroidectomy/hemithyroidectomy; lymphadenectomy | Up to 12 months. |
| Number of parathyroid glands identified before the use of AF (Autofluorescence) | Gland count | Up to 12 months. |
| Number and location of parathyroid glands identified with the use of FA (Autofluorescence) | Gland count | Up to 12 months. |
| Quantification of each parathyroid gland with AF(Autofluorescence) | (two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist | Up to 12 months. |
| Number of glands accidentally removed. | Gland count | Up to 12 months. |
| Number of autotransplanted glands. | Gland count | Up to 12 months. |
| Surgical time. | Hours of surgery | Up to 12 months. |
| Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve) | Number of surgeries using autofluorescence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Febrero, MD | Contact | 968 36 95 00 | beatriz.febrero@um.es |
| Name | Affiliation | Role |
|---|---|---|
| Beatriz Febrero, MD | HCUVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
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| ID | Term |
|---|---|
| D005453 | Fluorescence |
| ID | Term |
|---|---|
| D049449 | Luminescence |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
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PROSPECTIVE, CONTROLLED, RANDOMIZED
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| Up to 12 months. |
| Concentration of PTH and calcium corrected by albumin and/or ionic | Value in analytics | 4, 24 Hours |
| Concentration of PTH and calcium corrected by albumin and/or ionic | Value in analytics | 6,12 Months |
| D060328 |
| Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |