Trials / Completed
CompletedNCT05043584
Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions
Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Regional Hospital West Jutland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fluobeam LX, Fluoptics, Grenoble, France | See arm description |
Timeline
- Start date
- 2021-09-15
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2021-09-14
- Last updated
- 2024-01-03
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05043584. Inclusion in this directory is not an endorsement.