A Comparative Analysis of Hypocalcemia Incidence in Patients Undergoing Thyroidectomy: Ligasure vs Conventional Ligation of Vessels by Knot Tying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of Participants With Hypocalcemia
研究概览
简要总结
This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of hypocalcemia in patients undergoing thyroidectomy using Ligasure versus conventional ligation of vessels by knot tying. Additionally, secondary outcomes such as operative time, intraoperative bleeding, length of hospital stay, and postoperative complications will be assessed to provide a holistic understanding of the two surgical approaches.
详细描述
Thyroidectomy is surgical removal of all or part of the thyroid gland, which is located in the front of the neck. Depending on how much thyroid tissue is removed, thyroidectomy could be classified into Total thyroidectomy, subtotal thyroidectomy, near total thyroidectomy and lobectomy.
In total thyroidectomy, the entire thyroid gland is removed. In thyroid lobectomy, one lobe of the thyroid gland is removed. In Thyroid lobectomy with isthmectomy, thyroid lobe along with the isthmus is removed. In Subtotal thyroidectomy, a small portion of the thyroid gland is left during the surgery. This portion is near the trachea, parathyroid glands and the recurrent laryngeal nerve. Indications for thyroidectomy are thyroid cancer, MNG, solitary thyroid nodule.
Complications of thyroidectomy include hoarseness or change in voice (33.3%), damage to parathyroid glands causing hypocalcaemia (54.4%), wound infection (3.4%), dysphagia (32.8%). Several risk factors may contribute to the occurrence of post-thyroidectomy complications, including age, gender, enlarged gland size, type of thyroid disease, presence of fibrosis and inflammation, extent of thyroidectomy, and lymph node dissection. Among these complications, hypocalcaemia and recurrent laryngeal nerve injury are the most frequently observed.
The superior and inferior parathyroid glands, located near the thyroid gland, play a vital role in calcium homeostasis by producing parathyroid hormone (PTH), which regulates calcium levels in the bloodstream.
Hypocalcemia, characterized by low serum calcium levels. It is a frequent and significant complication of thyroidectomy due to damage, ischemia, or removal of one or more of the parathyroid glands during surgery. It can be categorized into two main types, transient hypocalcemia and permanent hypocalcemia. The primary difference between these two types lies in the duration. Transient hypocalcemia lasts for 3 months after surgery, while permanent hypocalcemia persists for 3 months or longer after surgery.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both genders.
- •Age between 20 years to 50 years.
- •Patients undergoing Total thyroidectomy for benign thyroid disease.
排除标准
- •Patients having pre-operative hypocalcaemia.
- •Patients having malignant thyroid disease.
- •Patients having recurrent thyroid disease.
- •Patients having lobectomy + isthmectomy.
- •Patients having pro-operative calcium supplements.
研究组 & 干预措施
Ligasure
Ligasure is a bipolar vascular sealing system utilized to achieve effective control of bleeding and create a bloodless surgical environment. It operates by utilizing an electrical current within the frequency range of 2-4 MHz It induces denaturation of collagen and elastin within the vessels and surrounding tissues. The localized tissue temperatures typically range between 60-100°C, facilitating the fusion of collagen and elastin in the vessel walls. This fusion process creates a durable sealed zone without any carbonization and enables hemostasis in vessels with diameters of up to 7 mm
干预措施: Using Ligasure for heamostasis (Device)
Knot tying
Conventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers
干预措施: Use of conventional knot tying technique for heamostasis (Procedure)
结局指标
主要结局
Number of Participants With Hypocalcemia
时间窗: 2 Days
次要结局
未报告次要终点
研究者
Zain Himayoun
Principal Investigator (Post Graduate Resident)
University of Health Sciences Lahore