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临床试验/NCT03777033
NCT03777033Unknown不适用

Systematic Administration vs on Demand Administration of Calcium and Vitamin D After Thyroidectomy. A Randomized Control Trial

Hellenic Red Cross Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2015年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Length of hospital stay in days

研究概览

简要总结

Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology. The investigators intent to study a new protocol with oral calcium and vitamin D given systematically from the day of operation to assess if this practice can minimize the rate of transient hypocalcaemia and as a consequence minimize the length of stay in the hospital.

详细描述

Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology.

Group A = control group will be managed as usual. Oral or IV supplements of Calcium will be giver on demand and recorded according to the clinical picture or the biochemical hypocalcaemia.

Group B= study group will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days) The investigators intent to minimize the immediate transient hypocalcaemia rate and give time to the parathyroids which may have been bruised or have compromised function initially to recover by day 15.

The 1st and 2nd postoperative day the invastigators are going to take blood samples and assess the 25 hydroxy vit D, the parathyroid hormone (PTH) and the Ca++. The investigators will also assess the calcium levels after the first week and if necessary ( in cases with longstanding hypocalcaemia ) in later day.

The patients will be discharged from the hospital the day after the operation provided the calcium levels are within normal range and they are completely asymptomatic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thyroid pathology only
  • No calcium metabolism problems
  • Total / near total thyroidectomy

排除标准

  • Renal failure,
  • Secondary hyperparathyroidism,
  • Primary hyperparathyroidism,
  • thyroid lobectomy,
  • Thyroid reoperation

研究组 & 干预措施

Study group

Experimental

Intervention: the patients will be given prophylactically ca and vit D. Patients after thyroidectomy will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb Intervention: The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days)

干预措施: Prophylactic protocol with Ca and Vit D (Drug)

结局指标

主要结局

Length of hospital stay in days

时间窗: From the day of the operation until a week after the operation

how many days the patient remained in the hospital

blood calcium levels (mg/dl) on the 1st postoperative day

时间窗: From the end of the operation until 24 hours after the operation

blood calcium measured in a blood sample in mg/dl

blood calcium levels (mg/dl) on the 2nd postoperative day

时间窗: From the end of the operation until 48 hours after the operation

blood calcium measured in a blood sample in mg/dl

次要结局

  • Overall cost of the treatment ( euros)(From the day of the operation until a month from the operation)

研究者

发起方
Hellenic Red Cross Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sophocles Lanitis

M.D, PhD, Consultant in General Surgery

Hellenic Red Cross Hospital

研究点 (1)

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