Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autofluorescence
- Sponsor
- Regional Hospital West Jutland
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Rate of hypoparathyroidism
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.
Detailed Description
Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery. PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.
Investigators
Ali Abood
Principal Investigator
Regional Hospital West Jutland
Eligibility Criteria
Inclusion Criteria
- •Patients referred for total thyroidectomy
- •Age \> 18
- •Able to understand patient information
- •Able to give informed consent
Exclusion Criteria
- •Previous thyroid surgery
- •Need for accelerated surgery
- •Insufficient biochemical profile
Outcomes
Primary Outcomes
Rate of hypoparathyroidism
Time Frame: Will be assessed on postoperative day one, minimum two months and one year following surgery.
Secondary Outcomes
- Parathyroid autotransplantation rate(Will be assessed at the time of surgery)
- Parathyroid gland identification rate(Will be assessed at the time of surgery)
- Rate of inadvertently excised parathyroid glands(Will be assessed 1 month following surgery)