Function-Preserving Surgery for Parotid Tumors: Intracapsular Versus Superficial Parotidectomy; A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
Benign parotid gland tumors, such as pleomorphic adenoma and Warthin tumors, constitute the majority of salivary gland neoplasms. Surgical excision remains the primary treatment, traditionally achieved through superficial parotidectomy (SP). However, SP may lead to complications such as facial nerve dysfunction, Frey's syndrome, and aesthetic concerns. Intracapsular parotidectomy (ICP), a minimally invasive alternative, aims to minimize surgical morbidity while preserving oncologic safety. This study aimes to compare intracapsular parotidectomy and superficial parotidectomy in terms of operative efficiency, complications, facial nerve preservation, and tumor recurrence for benign parotid tumors.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 65 years,
- •radiologically and clinically confirmed benign parotid tumor
- •tumor confined to the superficial or deep lobe without evidence of facial nerve involvement.
排除标准
- •suspicion of malignancy based on imaging or fine-needle aspiration cytology (FNAC)
- •recurrent parotid tumors
- •previous parotid surgery
- •facial nerve dysfunction preoperatively
- •comorbidities precluding surgery.
结局指标
主要结局
Operative time
时间窗: Intraoperatively
Blood Loss
时间窗: Introperative
Measuring the amount of blood loss introperatively
recurrence rate
时间窗: 6 months postopeartively
次要结局
未报告次要终点
研究者
Sayed Abd El Bary
Prinicipal Investigator
Al-Azhar University