Systematic Administration of Calcium and Vitamin D After Thyroidectomy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
In case of symptoms after the discharge the patients will be managed accordingly and this will be recorded in the records of each patient
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Group Patients after thyroidectomy 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. |
|
| Experimental: Study group 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) |
Drug: Prophylactic protocol with Ca and Vit D
3g calcium /day for 5 days and then 2g/day for 10 days 2 Micrograms Alfacalcidol/day and then 1 microgram /day for 10 days
the Prophylactic protocol with Ca and Vit D will be given in the form of Alfacalcidol 0.5 Micrograms Capsule and CALCIUM CARBONATE + CALCIUM GALACTOGLUCONATE 1000mg tablet
Other Names:
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Outcome Measures
Primary Outcome Measures
- blood calcium levels (mg/dl) on the 1st postoperative day [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 [From the end of the operation until 48 hours after the operation]
blood calcium measured in a blood sample in mg/dl
- Length of hospital stay in days [From the day of the operation until a week after the operation]
how many days the patient remained in the hospital
Secondary Outcome Measures
- Overall cost of the treatment ( euros) [From the day of the operation until a month from the operation]
how did this practice affected the cost of treatment of the patients
Eligibility Criteria
Criteria
Inclusion Criteria:
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Thyroid pathology only
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No calcium metabolism problems
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Total / near total thyroidectomy
Exclusion Criteria:
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Renal failure,
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Secondary hyperparathyroidism,
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Primary hyperparathyroidism,
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thyroid lobectomy,
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Thyroid reoperation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, | Athens | Greece | 11636 |
Sponsors and Collaborators
- Hellenic Red Cross Hospital
Investigators
- Principal Investigator: Sophocles Lanitis, Korgiallenio benakeio hellenic red cross hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis.
- Role of postoperative vitamin D and/or calcium routine supplementation in preventing hypocalcemia after thyroidectomy: a systematic review and meta-analysis.
Publications
None provided.- Ca/vitD in thyroidectomy