Thyroidectomy is a common operation. Transient postoperative hypocalcemia is the main complication, resulting in clinical discomfort for patients, longer hospital stays and increased perioperative cost. Cholecalciferol is used to supplement vitamin D deficiency. We suppose that systematic pre-operative supplementation with cholecalciferol would allow a faster and more appropriate response to post-operative hypocalcemia. MedDRA version: 20.1 Level: LLT Classification code 10020949 Term: Hypocalc
Conditions
Interventions
Trade Name: UVEDOSE 100 000 UI
Pharmaceutical Form: Oral solution in single-dose container
Sponsors
Hospital Center René Dubos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient = 18 years old Patient shall be operated on for a total thyroidectomy in one time for any indication Written informed consent (IC) obtained Patients with affiliation to the social security system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Medical history of : - thyroid or parathyroid surgery - Hyperparathyroidism - granulomatosis flare-up Chronic kidney disease grade =4 25OHD supplementation within last 3 months before surgery Malabsorption syndrome Known hypersensitivity to vitamin D Medical history of calcic lithiasis Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies Severe liver failure Pregnant women Vulnerable populations (guardianship or trusteeship) Persons deprived of their liberty by court or administrative decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy;Secondary Objective: Group Treatment vs group no treatment: Assessment of length of hospital stay and readmissions during follow-up Assessment of severity of hypocalcemia Assessment of the effect of supplementation on vitamin D deficiency Assessment of parathyroid activity All the patients: Assessment of the prevalence of definitive hypocalcemia Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy;Primary end point(s): Measure of the occurrence of serum and / or clinical hypocalcemia Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15 ;Timepoint(s) of evaluation of this end point: Fifteen days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of initial hospitalization (number of hospital days), collect of adverse events and number of readmissions Measure of severity of hypocalcemia defined by a calcemia corrected for albuminemia of less than 1.90 mmol / L and / or the use of calcium gluconate IV in the first 15 post-operative days. Measure of duration of hypocalcemia's symptoms in the first 15 days postoperative Vitamin D deficiency will be measured by comparing the initial value of 25OHD at the inclusion visit to the value of 25OHD of the day of the operation (D0=H0) Collect of the number of adverse events and serum calcium levels for each participant Collect of the definitive hypocalcemia’s numbers in each group Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L. ;Timepoint(s) of evaluation of this end point: At M3 | — |
Countries
France
Contacts
Public ContactClinical research unit
Hospital Center René Dubos
Outcome results
None listed