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

Al-Azhar University

Status: Completed

Conditions: Parotidectomy; Parotid Tumors

Treatments: Procedure: Intracapsular parotidectomy (ICP); Procedure: Superficial parotidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07185542

Parotid Tumors Surgery

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intracapsular parotidectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Intracapsular parotidectomy (ICP)

Superficial parotidectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Superficial parotidectomy