Wolak Stefanie, Scheunchen Mandy, Holzer Katharina, Busch Mirjam, Trumpf Esra, Zielke Andreas
Sana-Klinikum Offenbach, Chirurgische Klinik, Starkenburgring 66, 63069, Offenbach am Main, Germany.
Universitätsklinikum der Goethe-Universität Frankfurt, Fachbereich Zahnmedizin, 60590, Frankfurt, Germany.
Trials. 2016 Feb 20;17(1):101. doi: 10.1186/s13063-016-1216-5.
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.
METHODS/DESIGN: 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 endpoint measure (number of patients with hypocalcaemia), hypocalcaemia is defined as serum calcium of less than 2.1 mmol/l on any day during the postoperative course; this measure will be analyzed using a Chi-square test comparing the two groups. Secondary endpoint measures, such as number of days to discharge, quality of life, and economic parameters will also be analyzed.
By virtue of the direct comparison of clinically and economically relevant endpoints, the efficacy as well as efficiency of preoperative calcitriol prophylaxis of hypocalcaemia will be clarified. These results should be available 24 months after the first patient has been enrolled. The results will be used to inform a revised practice parameter guideline of whether or not to recommend preoperative calcitriol for all patients in whom total thyroidectomy is planned.
Deutsches Register Klinischer Studien, DRKS00005615 (Feb.12.2016).
全甲状腺切除术越来越多地被用作治疗多种甲状腺疾病的手术方法。随后，术后低钙血症的发生率日益增加，常导致住院时间延长、资源使用增加、生活质量下降以及工作恢复延迟。维生素D的补充在术后低钙血症的治疗中至关重要；骨化三醇是最常用的。目前尚未研究的是，使用骨化三醇进行常规术前维生素D预防是否以及如何有助于预防术后低钙血症。本研究评估了对所有拟行全甲状腺切除术的患者进行常规术前骨化三醇预防的效果，并与当前的治疗标准（即对术后低钙血症患者进行选择性维生素D治疗）进行比较。
方法/设计：本临床观察性（最小干预临床试验）试验是一项采用适应性设计的多中心、前瞻性、随机优效性试验。数据集将进行匿名化分析。患者将被随机分配（1:1）至干预组和对照组。唯一的干预措施是在手术前3天每天口服两次0.5μg骨化三醇。对于主要终点指标（低钙血症患者数量），低钙血症定义为术后任何一天血清钙低于2.1mmol/L；将使用卡方检验对两组进行比较分析该指标。还将分析次要终点指标，如出院天数、生活质量和经济参数。
通过对临床和经济相关终点的直接比较，将阐明术前骨化三醇预防低钙血症的疗效和效率。在第一名患者入组24个月后应可获得这些结果。这些结果将用于为修订后的实践参数指南提供参考，以决定是否对所有计划行全甲状腺切除术的患者推荐术前使用骨化三醇。
德国临床试验注册中心，DRKS00005615（2016年2月12日）。
