Impact of preoperative Vitamin D3 administration on postoperative hypocalcaemia in patients undergoing total thyroidectomy (HypoCalViD): study protocol for a randomized controlled trial

Trials
Stefanie WolakAndreas Zielke

Abstract

Total thyroidectomy is increasingly used as a surgical approach for many thyroid conditions. Subsequently, postoperative hypocalcaemia is observed with increasing frequency, often resulting in prolonged hospital stay, increased use of resources, reduced quality of life and delayed return to work. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia; calcitriol is most commonly used. What has not been examined so far is whether and how routine preoperative vitamin D prophylaxis using calcitriol can help to prevent postoperative hypocalcaemia. This study evaluates routine preoperative calcitriol prophylaxis for all patients who are to undergo a total thyroidectomy, compared with the current standard of post-treatment, i.e., selective vitamin D treatment for patients with postoperative hypocalcaemia. This clinical observational (minimal interventional clinical trial) trial is a multicentre, prospective, randomized superiority trial with an adaptive design. Datasets will be pseudonymized for analysis. Patients will be randomly allocated (1:1) to the intervention and the control groups. The only intervention is 0.5 μg calcitriol orally twice a day for 3 days prior to surgery. For the primary end...Continue Reading

References

Aug 18, 2005·American Journal of Surgery·Francesco TartagliaFrancesco P Campana
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Mar 7, 2014·Der Chirurg; Zeitschrift für alle Gebiete der operativen Medizen·H DralleA Machens

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Citations

Apr 11, 2018·Der Chirurg; Zeitschrift für alle Gebiete der operativen Medizen·S CoerperW Stengl
Oct 28, 2021·Deutsches Ärzteblatt International·Stephanie SonnenbergAndreas Zielke

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Software Mentioned

Random Allocation Software
HypoCalViD

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