Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surge
| Condition(s) | Hypocalcemia, Parathyroid, Hypoparathyroidism Post-surgical, Total Thyroidectomy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice. |
| Who can participate | Inclusion Criteria: * Adult patients ≥18 years of age * Undergoing total thyroidectomy, or completion total thyroidectomy * Pre-operative serum adjusted calcium levels within normal ranges Exclusion Criteria: * Patients on pre-operative calcium or vitamin D supplements * Patients with pre-operative vitamin D deficiency, defined as serum vitamin D\<30nmol/L * Patients with untreated primary or secondary hyperparathyroidism * Patient with known non-surgical hypoparathyroidism diseases * Patients with estimated glomerular filtration rate \<30ml/1.73m2/min, on dialysis, or having a history of kidney transplant |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The University of Hong Kong |
| Locations | Hong Kong, Hong Kong |
| Start date | 2025-09-16 |
| NCT ID | NCT07416149 |
| Official listing | https://clinicaltrials.gov/study/NCT07416149 |