Investigation of the use of special camera technology during thyroid surgery to avoid the need for calcium supplementation after surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: This study will include patients undergoing total thyroidectomy, with or without neck lymph node dissection. In the first arm, the autofluorescence technique will be used for the intraoperative detection of parathyroid glands. In the second arm, patients will have a conventional operation. The allocation of the patients will be random with the use of computer software, neither the patient nor the surgeon will have a choice. Postoperatively, all patients will have the required blood tests and clinical examination, required to identify those who may develop hyperparathyroidism. The final follow up will take place 6 months after the operation to conclude if the possible postoperative hyperparathyroidism is temporary or permanent. CONDITION: Prevention of postoperative hypoparathyroidism in patients undergoing thyroid operations ; Nutritional, Metabolic, Endocrine ; Postprocedural hypoparathyroidism PRIMARY OUTCOME: ; 1. Total calcium levels measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months; 2. Albumin measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months; 3. Phosphorous measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months; 4. Intact parathormone levels measured using a blood test (chemiluminescence immunoassay) at baseline, 1 day, 1 week, and 6 months; 5. 25‐OH‐Vit D measured using a blood test (chemiluminescence immunoassay) at baseline; SECONDARY OUTCOME: ; 1. Number of parathyroid glands detected intraoperatively measured using autofluorescence or direct visualisation during the operation; 2. Number of unintentional removals of parathyroid glands measured using the histopathology report at 1 month (after receiving the official report); 3. Number of autotransplantation of parathyroid glands measured using operation notes at day 1; INCLUSION CRITERIA: Patients over 18 years old undergoing total thyroidectomy with or without neck lymph node dissection
Epistemonikos ID: 09ed9e6558c6649fe8bcd04f0bc9ae2f6ee730cf
First added on: Aug 25, 2024