Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
研究概览
简要总结
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Malabsorption syndrome
- •Known hypersensitivity to vitamin D
- •Medical history of calcic lithiasis
- •Pregnant women
- •Vulnerable populations (guardianship or trusteeship)
- •Allergies to one of the components of the fruit juice
研究组 & 干预措施
Vitamin D
During preoperative visit (Month -2) patients will receive a cholecalciferol supplementation added to a fruit juice.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
时间窗: 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
次要结局
- Comparison of parathyroid activity in both arm(At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15)
- Assessment of the prevalence of definitive hypocalcemia(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(At Day 15)
- Comparison of clinical course in both Arm(At 3 month)
- Comparison of severity of hypocalcemia in both arm(At Day 1, Day 2 and Day 15)
- Comparison of the effect of supplementation on vitamin D deficiency in both arm(At Day 0)