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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000526-64 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice. |
|
| Fruit juice | No Intervention | During preoperative visit (Month -2) patients will receive only fruit juice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Patients will receive a cholecalciferol supplementation added to a fruit juice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Day 15 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| At 3 month |
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Inclusion Criteria:
Exclusion Criteria:
• Medical history of : Thyroid or parathyroid surgery Hyperparathyroidism Granulomatosis flare-up
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryline Delattre | Contact | +33 1 30 75 41 31 | maryline.delattre@ght-novo.fr | |
| Veronique Da Costa | Contact | +33 1 30 75 50 69 | veronique.dacosta@ght-novo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dr Khaled AL TABAA | Hôpital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Digestive and Endocrine Surgery | Terminated | Auxerre | 89000 | France | ||
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| ID | Term |
|---|---|
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 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 :
|
| 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. | 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. | 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 | 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 | At Day 15 |
| Department of ENT and maxillofacial surgery |
| Recruiting |
| Corbeil-Essonnes |
| 91100 |
| France |
|
| Department of Head and Neck Surgery and ENT | Recruiting | La Roche-sur-Yon | 85000 | France |
|
| Hospital Lariboisière, Paris X | Terminated | Paris | 75010 | France |
| Hospital Poissy/Saint-Germain | Recruiting | Poissy | 78300 | France |
|
| Hospital René Dubos, | Recruiting | Pontoise | 95300 | France |
|