Hypoparathyroism after thyroid surgery Too little or no hormone from the parathyroid glands after thyroid surgery
Conditions
Interventions
To study the performance of LSCI, a non-invasive, contrast-free intraoperative imaging approach combining ICG-to assess parathyroid perfusion during thyroidectomy, with the aim of predicting postopera
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients scheduled to undergo a total thyroidectomy, a hemithyroidectomy with probability of a completing thyroidectomy (PET positive lesion, Bethesda 3 or 4 lesion >2cm, Bethesda 5 and 6 lesion irrespective of the size of the lesion, clinical of radiological suspicion of bilateral disease, clinical or radiological evidence of local invasion, known genetic syndromes or high-risk family history, or as determined by the expertise of an endocrine surgeon) or a completing thyroidectomy.Indication for the scheduled surgery can be both benign or malignant.The age must be 18 years old or above.Written informed consent.
Exclusion criteria
Exclusion criteria: Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.Acute procedures where there is <48 h for the patients to assess whether to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in intraoperatively quantified parathyroid perfusion measurements between patients with and without postoperative hypoparathyroidism, specifically: LSCI-derived laser speckle perfusion units (LSPU). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare perfusion measurements from LSCI to establish optimized combined threshold values that accurately differentiate well-perfused from poorly perfused parathyroid glands during thyroid surgery. To evaluate the diagnostic performance of LSCI in predicting postoperative hypoPT. To assess the intraoperative subjective evaluation of parathyroid gland perfusion by the operating surgeon and compare it with objective LSCI imaging and perfusion measurements and postoperative outcomes. Prospectively assess the quality of life of patients with and without postoperative hypoPT using the SF-36 questionnaire. | — |
Countries
Netherlands
Contacts
Public ContactSJM Polman
Martini Ziekenhuis
Outcome results
None listed