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

NCT07185542 | Completed DMC

• 1 other identifier: Parotid Tumors Surgery
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Parotid Tumors; Parotidectomy

Outcome Measures

Primary Outcomes (3)

• Operative time

  Intraoperatively

• Blood Loss

  Measuring the amount of blood loss introperatively

  Introperative

• recurrence rate

  6 months postopeartively

Study Arms (2)

Intracapsular parotidectomy

ACTIVE COMPARATOR

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

Procedure: Intracapsular parotidectomy (ICP)

Superficial parotidectomy

ACTIVE COMPARATOR

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: Superficial parotidectomy

Interventions

Superficial parotidectomy PROCEDURE

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

Superficial parotidectomy

Intracapsular parotidectomy (ICP) PROCEDURE

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

Intracapsular parotidectomy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar university

Madīnat an Naşr, Cairo Governorate, 4450113, Egypt

Location

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 5, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

EG (1)