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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07185542

Enrollment

120

Registered

2025-09-22

Start date

2024-05-01

Completion date

2025-05-05

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parotidectomy, Parotid Tumors

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.

Interventions

PROCEDURESuperficial 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

PROCEDUREIntracapsular 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Operative time	Intraoperatively	—
Blood Loss	Introperative	Measuring the amount of blood loss introperatively
recurrence rate	6 months postopeartively	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026