AIM OF THE STUDY
The aim of the proposed clinical trial is to prove in a prospective assessment that “parathyroid splinting” is the best approach for the medical management of acute postoperative parathyroid insufficiency in terms of early (one month) and late (one year) parathyroid function recovery.
PATIENTS AND METHODS
Design. Prospective open-label randomized clinical trial comparing two dosages of substitutive treatment with calcium and calcitriol (low/supportive vs high/suppressive dosages) for the treatment of acute postoperative parathyroid insufficiency after bilateral thyroidectomy. The primary variable will be iPTH serum concentration and percentage of parathyroid function recovery in each group at one postoperative month. The secondary variables will be percentage of parathyroid function recovery in each group during the one year follow-up and the prevalence of permanent hypoparathyroidism (defined as iPTH<13 pg/ml plus treatment with calcium and/or calcitriol (in the absence of hypercalcaemia) one year after thyroidectomy in each group. Sponsor:
Multicentre study at referral Endocrine Surgery Units across Europe.