Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of participants with permanent facial nerve palsy
研究概览
简要总结
The most common benign tumor of the parotid gland is the so called pleomorphic adenoma. Although benign, this tumor may recur after surgical removal due to tumor cells left behind during the surgical operation. Thus, pleomorphic adenomas have been treated with wide resection similar to malignant tumors. This extensive surgery often leads to injury to the motor nerves responsible for facial expression and eye protection. The investigators propose less extensive surgery which should be thorough enough to prevent tumor recurrence while keeping the facial nerve out of risk.
详细描述
Pleomorphic adenoma is notorious of its propensity to local recurrence due to the microscopic extracapsular extension of the tumor. Superficial parotidectomy (SP) is the standard treatment. Extracapsular dissection (ED) has been proposed to minimize the risk of facial nerve palsy. However, the oncologic safety of ED is controversial in the literature. We propose quadrant parotidectomy (QP) which is less radical than SP and less conservative than ED. QP entails dissection overlying one primary division of the facial nerve leaving the other division undisturbed while the resection safety margin is still generous.
Surgery for pleomorphic adenoma is a compromise between radicality and facial nerve morbidity. Risk of local recurrence is imprecisely described in the literature and is universally regarded as infrequent and remote. Many studies did not report recurrent cases. Thus, Facial nerve injury is the main concern of parotid surgeons and is considered the primary end point of this study.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis
排除标准
- •Collagen diseases
- •Previous parotid surgery
- •Previous facial nerve palsy
- •Neuromuscular diseases affecting the face
- •Patient refusal
结局指标
主要结局
Number of participants with permanent facial nerve palsy
时间窗: measured six months after the date of surgery
using clinical neurological examination
次要结局
- Operative time in minutes(Measured at the time of surgery)
- Number of participants with temporary facial nerve palsy(Measured at one day and at three months from the date of surgery.)
研究者
Osama Hussein
Associate Professor of Surgery
Mansoura University