Endoscopic Versus Conventional Parotidectomy for Benign Parotid Tumors (miniparo)
Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study
研究概览
地位
条件
详细说明
Parotid gland tumors account for approximately 3-6% of all head and neck tumors, and nearly 70-80% arise from the superficial lobe of the gland, with the majority being benign lesions such as pleomorphic adenoma and Warthin tumor . A considerable proportion of these tumors occur in the inferior pole of the parotid gland, where surgical management aims to achieve complete tumor excision while preserving facial nerve function and maintaining satisfactory cosmetic outcomes .
Conventional parotidectomy performed through a modified Blair incision remains the standard surgical approach for benign parotid tumors . This technique offers adequate surgical exposure and good tumor control; however, it is associated with several limitations including visible facial scarring, potential facial nerve injury, Frey's syndrome, and postoperative sensory disturbances .
In recent years, minimally invasive surgical approaches have been introduced to overcome these limitations. Endoscopic parotidectomy has emerged as a promising technique for selected benign parotid tumors. The magnified endoscopic view may facilitate more precise dissection and improved identification of facial nerve branches while allowing smaller incisions and potentially better cosmetic outcomes .
Despite encouraging results reported in several studies, the available evidence comparing endoscopic parotidectomy with the conventional approach remains limited. Therefore, further prospective comparative studies are required to evaluate the safety, efficacy, and cosmetic advantages of this minimally invasive technique.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Asyut、埃及、2063045
- Department of General Surgery, Maxillofacial and Head and Neck Unit
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 18 years or older
- Patients with benign parotid tumors involving the superficial lobe of the parotid gland
- Tumors located in the inferior pole with or without limited deep lobe extension
- Tumor size suitable for minimally invasive approach ≤4 cm
- Patients fit for surgery under general anesthesia
- Patients willing to provide informed consent and comply with follow-up
Exclusion Criteria:
- Recurrent parotid tumors
- Previous parotid surgery on the affected side
- Pre-existing facial nerve dysfunction
- Previous neck surgery or extensive cervical/anterior chest wall scarring
- Significant comorbidities contraindicating surgery or general anesthesia
- Suspected or confirmed malignant parotid tumors
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Endoscopic Parotidectomy Group
Experimental Arm Endoscopic Parotidectomy
|
Minimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors.
|
|
有源比较器:Conventional Open Parotidectomy Group
Conventional Parotidectomy
|
Conventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical safety and feasibility
大体时间:During surgery and up to 3 months postoperatively.
|
Assessment of intraoperative and postoperative complications and conversion rate to open surgery.
|
During surgery and up to 3 months postoperatively.
|
|
Facial nerve function
大体时间:24 hours, 1 week, 1 month, and 3 months postoperatively.
|
Assessment using House-Brackmann grading system.
|
24 hours, 1 week, 1 month, and 3 months postoperatively.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Intraoperative blood loss
大体时间:Intraoperative
|
Intraoperative
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- endo-parotidectomy
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.