CAVITHY: Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|Experimental: Vitamin D
During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice.
Drug: Vitamin D
Patients will receive a cholecalciferol supplementation added to a fruit juice.
|No Intervention: Fruit juice
During preoperative visit (Month -2) patients will receive only fruit juice.
Primary Outcome Measures
- Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy [At Day 15 after surgery]
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
Secondary Outcome Measures
- Comparison of clinical course in both Arm [At 3 month]
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)
- Comparison of severity of hypocalcemia in both arm [At Day 1, Day 2 and Day 15]
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
- Comparison of the effect of supplementation on vitamin D deficiency in both arm [At Day 0]
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.
- Comparison of parathyroid activity in both arm [At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15]
Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L.
- Assessment of the prevalence of definitive hypocalcemia [At Day 15]
Collect of the definitive hypocalcemia's numbers in each group
- Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy [At Day 15]
Collect of the number of adverse events and serum calcium levels for each participant
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
• Medical history of : Thyroid or parathyroid surgery Hyperparathyroidism Granulomatosis flare-up
Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies
Chronic kidney disease grade ≥4
Severe liver failure
25OHD supplementation within last 3 months before surgery
Known hypersensitivity to vitamin D
Medical history of calcic lithiasis
Vulnerable populations (guardianship or trusteeship)
Contacts and Locations
|1||Hospital Lariboisière, Paris X||Paris||France||75010|
|3||Hospital René Dubos,||Pontoise||France||95300|
Sponsors and Collaborators
- Centre Hospitalier René Dubos
- Principal Investigator: Dr Khaled AL TABAA, Centre Hospitalier René Dubos
Study Documents (Full-Text)None provided.
- CHRD 2115