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NCT Number: NCT07185542

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

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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university

Madīnat an Naşr, Cairo Governorate, 4450113, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Operative time

    Time frame: Intraoperatively

  2. Blood Loss

    Time frame: Introperative

    Measuring the amount of blood loss introperatively

  3. recurrence rate

    Time frame: 6 months postopeartively

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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