Thyroid Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREFluorescence in thyroid surgery
Fluorescence in thyroid surgery
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
PROSPECTIVE, CONTROLLED, RANDOMIZED
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type of surgery performed | Up to 12 months. | total thyroidectomy/hemithyroidectomy; lymphadenectomy |
| Number of parathyroid glands identified before the use of AF (Autofluorescence) | Up to 12 months. | Gland count |
| Number and location of parathyroid glands identified with the use of FA (Autofluorescence) | Up to 12 months. | Gland count |
| Quantification of each parathyroid gland with AF(Autofluorescence) | Up to 12 months. | (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 |
| Number of glands accidentally removed. | Up to 12 months. | Gland count |
| Number of autotransplanted glands. | Up to 12 months. | Gland count |
| Surgical time. | Up to 12 months. | Hours of surgery |
| Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve) | Up to 12 months. | Number of surgeries using autofluorescence |
| Concentration of PTH and calcium corrected by albumin and/or ionic | 4, 24 Hours | Value in analytics |
Countries
Spain
Contacts
Primary ContactBeatriz Febrero, MD
Outcome results
None listed