Clinical trial · Interventional
Function-Preserving Surgery for Parotid Tumors: Intracapsular Versus Superficial Parotidectomy; A Randomized Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parotidectomy | — | UNRESOLVED | — |
| Parotid Tumors | Parotid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intracapsular parotidectomy (ICP) | Procedure | — | UNRESOLVED |
| Superficial parotidectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intracapsular parotidectomy
- 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
- interventionNames
- Procedure: Intracapsular parotidectomy (ICP)
- type
- ACTIVE_COMPARATOR
- label
- Superficial parotidectomy
- 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
- interventionNames
- Procedure: Superficial parotidectomy
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available