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临床试验/NCT07597096
NCT07597096尚未招募不适用

COMPARISON OF THE EFFICACY BETWEEN PREOPERATIVE CALCIUM & VITAMIN D3 VERSUS CALCIUM SUPPLEMENTATION ALONE TO PREVENT POST OPERATIVE SYMPTOMATIC HYPOCALCEMIA AFTER TOTAL THYROIDECTOMY IN EUTHYROID PATIENTS

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年5月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
试验地点
1

研究概览

简要总结

Total thyroidectomy is a commonly performed surgery for thyroid diseases such as multinodular goiter. One of the most frequent complications after this procedure is hypocalcemia (low blood calcium levels), which may cause symptoms such as tingling around the mouth, muscle cramps, and in severe cases, spasms or confusion. This condition usually occurs within the first 24-72 hours after surgery and may delay hospital discharge and increase patient discomfort.

This study aims to compare the effectiveness of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in patients undergoing total thyroidectomy. Patients diagnosed with multinodular goiter and planned for surgery will be randomly assigned into two groups. One group will receive calcium with vitamin D3 for seven days before surgery, while the other group will receive calcium alone for the same duration.

After surgery, patients will be monitored for symptoms of hypocalcemia and their serum calcium levels will be checked at 6, 24, and 48 hours, as well as at a follow-up visit on day 14. The main outcome of the study is the occurrence of symptomatic hypocalcemia in both groups.

The results of this study may help determine whether adding vitamin D3 to preoperative calcium supplementation provides better protection against hypocalcemia after thyroid surgery, potentially improving patient outcomes and reducing hospital stay.

详细描述

Total thyroidectomy is a standard surgical procedure performed for benign and malignant thyroid disorders, particularly multinodular goiter. Despite being a safe operation, one of its most common and clinically significant complications is postoperative hypocalcemia, which primarily results from transient or permanent impairment of parathyroid gland function due to devascularization, inadvertent removal, or surgical trauma. Symptomatic hypocalcemia typically occurs within 24-72 hours after surgery and may present with neuromuscular irritability such as perioral numbness, paresthesia, muscle cramps, carpopedal spasm, tetany, or, in severe cases, cardiac arrhythmias. This complication can lead to prolonged hospital stay, increased patient morbidity, and higher healthcare costs.

Various strategies have been proposed to reduce the incidence and severity of post-thyroidectomy hypocalcemia, including routine postoperative calcium supplementation, selective supplementation based on serum calcium or parathyroid hormone levels, and preoperative administration of calcium and vitamin D3. Vitamin D3 plays a key role in calcium homeostasis by enhancing intestinal calcium absorption and improving postoperative calcium balance, potentially reducing the risk of symptomatic hypocalcemia when administered preoperatively along with calcium.

This randomized controlled trial is designed to compare the efficacy of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in euthyroid patients undergoing total thyroidectomy for multinodular goiter. Eligible patients will be randomized into two groups: one receiving oral calcium with vitamin D3 and the other receiving oral calcium alone for seven days prior to surgery.

Postoperatively, patients will be closely monitored clinically and biochemically. Serum corrected calcium levels will be measured at 6, 24, and 48 hours after surgery, and again at a 14-day follow-up visit. Parathyroid hormone levels will also be assessed at selected time points. Symptomatic hypocalcemia will be defined based on the presence of clinical features in combination with low serum calcium levels.

The study aims to determine whether preoperative vitamin D3 supplementation provides additional benefit over calcium alone in reducing the incidence of postoperative symptomatic hypocalcemia, thereby improving early postoperative recovery, reducing hospital stay, and optimizing perioperative management in thyroid surgery patients.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A) Age between 18 to 60 years B) Both genders C) Multiple nodular goiter diagnosed on the basis of history and investigation like thyroid function test , USG neck for TIRADS scoring and USG guided FNAC to confirm the diagnosis .
  • D) ASA grade 1 &2 E) With preserved one or two parathyroid gland

排除标准

  • A) Cardiovascular disease B) Deranged Renal parameters C) Pregnancy D) Concomitant endocrine pathology warranting the surgery

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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