Comparison of Outcomes of Microscopic Versus Conventional Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Mean intraoperative blood loss
研究概览
简要总结
Despite promising findings from international studies, the use of microscopic thyroidectomy remains limited in local surgical practice, where conventional thyroidectomy is traditionally followed. There is a scarcity of local data evaluating the benefits of MT, and inconsistencies in reported outcomes highlight the need for further research. The lack of standardized protocols and limited surgeon experience with microscopic techniques contribute to hesitation in its adoption.
This study aims to address the research gap by providing comparative data on operative time, intraoperative blood loss, and postoperative complications in microscopic versus conventional thyroidectomy in our setting. The findings will aid in determining whether MT should be incorporated into routine surgical practice to improve patient outcomes and reduce postoperative complications.
详细描述
Thyroid disorders requiring surgical intervention are common, with conditions such as multi nodular goiter, thyroid malignancies, and hyperthyroidism frequently necessitating thyroidectomy. The procedure, while effective, poses risks due to the intricate anatomy of the thyroid gland and its proximity to critical structures such as the recurrent laryngeal nerve (RLN), external branch of the superior laryngeal nerve (EBSLN), and parathyroid glands. Complications like RLN palsy, hypocalcemia, and hematoma can result in significant morbidity. Hypocalcemia occurs in 20%-30% of cases, while RLN injury is reported in 5%-11%, with bilateral RLN paralysis being a rare but life-threatening complication. Minimizing these risks requires precise surgical techniques, adequate anatomical knowledge, and surgeon expertise. Thyroid surgery has evolved significantly, incorporating various approaches to enhance safety and outcomes. Conventional thyroidectomy (CT) remains the standard procedure, providing direct visualization and effective gland excision. Endoscopic thyroidectomy, utilizing minimal access techniques, has improved cosmetic outcomes but often involves longer operative times. The use of robotic-assisted thyroidectomy has further advanced precision, though cost and availability remain limiting factors. Microscopic thyroidectomy (MT), which involves magnification techniques for enhanced visualization, has been introduced to minimize complications. Studies suggest MT offers superior preservation of RLN, EBSLN, and parathyroid glands, reducing transient nerve palsies and hypocalcemia rates compared to conventional approaches.
However, it is essential to assess its efficacy in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both Male or female patients.
- •Patients aged 18 to 65 years undergoing thyroidectomy for benign or malignant thyroid disease.
- •Patients with multinodular goiter, Grave's disease, thyroid carcinoma indicated for surgery based on their workup.
- •Candidates scheduled for unilateral lobectomy, subtotal thyroidectomy, or total thyroidectomy.
- •Patients with preoperative normal vocal cord mobility confirmed by laryngoscopy.
- •Hemodynamically stable patients without significant comorbidities affecting surgery or anesthesia based on ASA classification (Class I-III).
- •Patients who provide informed consent to participate in the study.
排除标准
- •Prior history of prior thyroid surgery.
- •Patients with evidence of lateral lymph node metastasis or local invasion on preoperative imaging (ultrasonography or computed tomography).
- •Patients with pre-existing hypocalcemia or parathyroid disorders.
- •Patients with severe medical comorbidities, including uncontrolled diabetes (HbA1c > 8%), chronic kidney disease (eGFR < 30 mL/min/1.73m²), liver cirrhosis (Child-Pugh class B or C), or coagulopathy (INR > 1.5 or platelet count < 50,000/μL), will be excluded from the study.
- •Pregnant or lactating women.
- •Patients with invasive thyroid carcinoma, anaplastic thyroid carcinoma, or thyroid lymphoma requiring extensive radical surgery.
结局指标
主要结局
Mean intraoperative blood loss
时间窗: 0 days
It will be defined as the mean total volume of blood lost during the surgical procedure, measured in milliliters (mL). Blood loss will be estimated using the difference between preoperative and postoperative suction canister volumes, accounting for irrigation fluids, and by weighing surgical sponges and gauze (1 g of blood = 1 mL).
Percentage of Transient Recurrent Laryngeal Nerve (RLN) Palsy
时间窗: one month
postoperative unilateral or bilateral impairment of vocal cord mobility due to RLN dysfunction, confirmed by indirect laryngoscopy or videolaryngostroboscopy performed by an otolaryngologist. Diagnosis will be based on reduced or absent vocal cord movement compared to preoperative assessment. Patients exhibiting hoarseness, breathiness, or dysphonia with confirmed vocal cord dysfunction on laryngoscopic evaluation within one month postoperatively will be labeled as transient RLN palsy. Any patient showing full recovery of vocal cord mobility on follow-up laryngoscopy at one month will be classified as transient.
Percentage of Permanent Recurrent Laryngeal Nerve (RLN) Palsy
时间窗: one month
persistent postoperative unilateral or bilateral vocal cord paralysis confirmed by indirect laryngoscopy or videolaryngostroboscopy at one month postoperatively by an otolaryngologist. Diagnosis will require complete absence of vocal cord movement on objective examination at one month, without any signs of recovery. Patients with persistent hoarseness, dysphonia, or aspiration symptoms accompanied by vocal cord immobility at one month will be definitively classified as having permanent RLN palsy.
percentage of Transient Hypocalcemia
时间窗: one month
It will be labeled as transient hypocalcemia if the patient experiences symptoms such as perioral numbness, carpopedal spasms, or tetany within one month of surgery, with laboratory confirmation of serum calcium \< 8.0 mg/dL. Diagnosis will be based on serial calcium measurements, and resolution within one month without continued supplementation will confirm its transient nature.
次要结局
未报告次要终点
研究者
Dr Mudassar Saeed Pansota
Associate Professor
Shahida Islam Medical Complex