跳至主要内容
临床试验/NCT07600112
NCT07600112进行中(未招募)不适用

Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study

Assiut University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
46
试验地点
1
主要终点
Surgical safety and feasibility

研究概览

简要总结

To compare endoscopic and conventional parotidectomy in the management of benign parotid tumors regarding surgical outcomes, facial nerve preservation, operative time, postoperative complications, and cosmetic results, in order to evaluate the safety, feasibility, and potential advantages of the endoscopic minimally invasive technique.

详细描述

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Endoscopic Parotidectomy Group

Experimental

Experimental Arm Endoscopic Parotidectomy

干预措施: Endoscopic Parotidectomy Group (Procedure)

Conventional Open Parotidectomy Group

Active Comparator

Conventional Parotidectomy

干预措施: Active Comparator Intervention Conventional Parotidectomy (Procedure)

结局指标

主要结局

Surgical safety and feasibility

时间窗: During surgery and up to 3 months postoperatively.

Assessment of intraoperative and postoperative complications and conversion rate to open surgery.

Facial nerve function

时间窗: 24 hours, 1 week, 1 month, and 3 months postoperatively.

Assessment using House-Brackmann grading system.

次要结局

  • Intraoperative blood loss(Intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohammed Hussein Ali

Principal Investigator

Assiut University

研究点 (1)

Loading locations...

相似试验

Endoscopic Versus Conventional Parotidectomy for... | 临床试验