This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
Thyroidectomy is a frequent procedure. This surgery is well known but not devoid of risks. The most common postoperative complication is transitory hypocalcemia. Some studies have reported that preoperative vitamin D deficiency (VDD) is a risk factor for hypocalcemia after total thyroidectomy (TT) in patients with non toxic multinodular goiter or graves's disease. Although the association between VVD and postoperative hypocalcemia in thyroid cancer patients undergoing TT plus central compartment neck dissection (CCND) remains unclear. This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing TT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Patients will receive a cholecalciferol supplementation added to a fruit juice.
Department of General, Digestive and Endocrine Surgery
Auxerre, France
TERMINATEDDepartment of ENT and maxillofacial surgery
Corbeil-Essonnes, France
RECRUITINGDepartment of Head and Neck Surgery and ENT
La Roche-sur-Yon, France
Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
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 day 15
Time frame: At Day 15 after surgery
Comparison of clinical course in both Arm
Clinical course will be measured, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below : * Initial hospital stay (number of days), * number of readmission, * adverse event (number)
Time frame: At 3 month
Comparison of severity of hypocalcemia in both arm
The severity of hypocalcemia will be measured in both arm, to see if a significant difference is observed, with items listed below : * Calcemia, corrected for albuminemia, of less than 1.90 mmol / L * the use of calcium gluconate IV in the first 15 post-operative days) * duration of hypocalcemia's symptoms in the first 15 days postoperative
Time frame: At Day 1, Day 2 and Day 15
Comparison of the effect of supplementation on vitamin D deficiency in both arm
Comparison between measured initial value of 25OHD at the inclusion visit to the measured value of 25OHD on the day of the operation in both groups.
Time frame: At Day 0
Comparison of parathyroid activity in both arm
Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH \< 15 ng / L.
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Hospital Lariboisière, Paris X
Paris, France
TERMINATEDHospital Poissy/Saint-Germain
Poissy, France
RECRUITINGHospital René Dubos,
Pontoise, France
RECRUITINGTime frame: At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15
Assessment of the prevalence of definitive hypocalcemia
Collect of the definitive hypocalcemia's numbers in each group
Time frame: At Day 15
Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy
Collect of the number of adverse events and serum calcium levels for each participant
Time frame: At Day 15