Study of Usefulness of Fluorescence in Thiroid Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery

Conditions
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Thyroid Surgery

Intervention / Treatment
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* Procedure: Fluorescence in thyroid surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total thyroidectomy with/without lymph node dissection Signature of informed consent Exclusion Criteria: Patients under 18 years of age Hemithyroidectomy Reintervention of thyroid surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PROSPECTIVE, CONTROLLED, RANDOMIZED
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence in thyroid surgery<br>Patients undergoing thyroid surgery with cervical fluorescence. | Procedure: Fluorescence in thyroid surgery<br>* Fluorescence in thyroid surgery<br>|
| No Intervention: No Fluorescence in thyroid surgery<br>patients undergoing thyroid surgery without cervical fluorescence. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |