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

Not Applicable

Completed

• Conditions: Parotid Tumors; Parotidectomy

• Registration Number: NCT07185542
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-05
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operative time	Intraoperatively
Blood Loss	Introperative	Measuring the amount of blood loss introperatively
recurrence rate	6 months postopeartively

Trial Locations

Locations (1)

Al-Azhar university; 🇪🇬 Madīnat an Naşr, Cairo Governorate, Egypt