Postoperative Complications Clinical Trial
Official title:
Is Correcting Total Serum Calcium Levels for Serum Albumin Necessary in Assessing Symptomatic Hypocalcemia After Total Thyroidectomy: a Prospective Cohort Study
This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. The aim of this study is to determine whether total serum calcium level should be corrected for serum albumin in assessing symptomatic hypocalcemia after total thyroidectomy and which variable (total serum calcium, ionized calcium, corrected serum calcium for albumin with Payne's formula or early PTH) is the most valuable predictor of symptomatic hypocalcemia after total thyroidectomy.
This study is designed as a prospective non-randomized longitudinal single- center cohort
study to evaluate the importance of correcting total serum calcium levels. It will enroll
around 100 patients undergoing total thyroidectomy with data being collected from March 2020
up to August 2020.The patients will be eligible if they undergo total thyroidectomy
regardless of the surgical indication, if complete serum PTH and calcium data are available
through the first five postoperative days and if they sign an informed consent form. Patients
with incomplete data, preoperative pathological calcium or PTH levels, or suffering from
conditions affecting calcium metabolism and parathyroid function will be excluded from the
study.
Demographic and clinical data including age, sex, preoperative and postoperative laboratory
values (total serum calcium, ionized calcium, corrected total serum calcium for serum albumin
and PTH), neck dissection procedures, and postoperative calcium supplement therapy will be
noted.
Primary outcome measures are presence of hypocalcemia on the first and fifth postoperative
day. Secondary outcome measures are the need for calcium supplement therapy during the first
five postoperative days, amount of medication given and correlation between presence of
symptoms and low values of corrected total serum calcium levels. Preoperative blood samples
for serum PTH and calcium measurements will be obtained after hospital admission.
Postoperative serum PTH will be sampled 1 hour after surgery and at 7 am on the firstand
fifth postoperative day. Serum calcium sampling will be performed daily if a patient has
hypocalcemia detected on the first postoperative day. Hypocalcemia is defined as serum
calcium levels < 2.00 mmol/L regardless of clinical symptoms present. Normal PTH range is
defined by the Department of Laboratory Diagnostics reference range - from 1.6 to 6.9 pmol/L.
The recovery of parathyroid function is defined as the return of serum PTH and serum calcium
to normal values, requiring no further calcium or vitamin D supplementation. If the patient
does not have laboratory or clinical signs of hypocalcemia, calcium supplement therapy will
not be administered. Supplement therapy will be administered in patients with laboratory
findings confirming hypocalcemia. Supplement therapy consists of either peroral elemental
calcium (calcium carbonate, 1-gram unit) or calcitriol (0.5 microgram unit) or both. If
postoperative calcium and PTH are normal and there are no symptoms of discomfort, the patient
will be discharged on the first or second postoperative day and serum PTH and calcium
sampling will be performed on an outpatient basis. If the patient did not receive treatment
during hospitalization, no supplements will be prescribed after hospital discharge.
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