Study of Usefulness of Fluorescence in Thiroid Surgery
- Conditions
- Thyroid Surgery
- Interventions
- Procedure: Fluorescence in thyroid surgery
- Registration Number
- NCT06011369
- Lead Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- Total thyroidectomy with/without lymph node dissection
- Signature of informed consent
- Patients under 18 years of age
- Hemithyroidectomy
- Reintervention of thyroid surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluorescence in thyroid surgery Fluorescence in thyroid surgery Patients undergoing thyroid surgery with cervical fluorescence.
- Primary Outcome Measures
Name Time Method Number of parathyroid glands identified before the use of AF (Autofluorescence) Up to 12 months. Gland count
Number of glands accidentally removed. Up to 12 months. Gland count
Number of autotransplanted glands. Up to 12 months. Gland count
Concentration of PTH and calcium corrected by albumin and/or ionic 6,12 Months Value in analytics
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
Type of surgery performed Up to 12 months. total thyroidectomy/hemithyroidectomy; lymphadenectomy
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain