A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thyroid Surgery
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
Time Frame: Up to 12 months.
Number of surgeries using autofluorescence
Type of surgery performed
Time Frame: Up to 12 months.
total thyroidectomy/hemithyroidectomy; lymphadenectomy
Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
Time Frame: Up to 12 months.
Gland count
Surgical time.
Time Frame: Up to 12 months.
Hours of surgery
Number of parathyroid glands identified before the use of AF (Autofluorescence)
Time Frame: Up to 12 months.
Gland count
Number of glands accidentally removed.
Time Frame: Up to 12 months.
Gland count
Number of autotransplanted glands.
Time Frame: Up to 12 months.
Gland count
Concentration of PTH and calcium corrected by albumin and/or ionic
Time Frame: 6,12 Months
Value in analytics
Quantification of each parathyroid gland with AF(Autofluorescence)
Time Frame: 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