NCT07185542

Function-Preserving Surgery for Parotid Tumors: Intracapsular Versus Superficial Parotidectomy; A Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parotid Tumors
• Parotidectomy

Interventions

Type	Name	Description
PROCEDURE	Superficial parotidectomy	Superficial parotidectomy (SP), the traditional approach, involves facial nerve dissection and removal of the superficial lobe. Though effective, it carries risks like nerve dysfunction, Frey's syndrome, and cosmetic concerns
PROCEDURE	Intracapsular parotidectomy (ICP)	ICP excises the tumor along its capsule without dissecting the facial nerve, thereby minimizing trauma and preserving glandular tissue. ICP is recommended for small, mobile, and superficially located benign tumors with low suspicion of malignancy. However, concerns remain regarding capsular rupture and recurrence, particularly in pleomorphic adenomas with microscopic extensions

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-01
• Completion: 2025-05-05
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Egypt