- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07600112
Endoscopic Versus Conventional Parotidectomy for Benign Parotid Tumors (miniparo)
Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study
Study Overview
Status
Conditions
Detailed Description
Parotid gland tumors account for approximately 3-6% of all head and neck tumors, and nearly 70-80% arise from the superficial lobe of the gland, with the majority being benign lesions such as pleomorphic adenoma and Warthin tumor . A considerable proportion of these tumors occur in the inferior pole of the parotid gland, where surgical management aims to achieve complete tumor excision while preserving facial nerve function and maintaining satisfactory cosmetic outcomes .
Conventional parotidectomy performed through a modified Blair incision remains the standard surgical approach for benign parotid tumors . This technique offers adequate surgical exposure and good tumor control; however, it is associated with several limitations including visible facial scarring, potential facial nerve injury, Frey's syndrome, and postoperative sensory disturbances .
In recent years, minimally invasive surgical approaches have been introduced to overcome these limitations. Endoscopic parotidectomy has emerged as a promising technique for selected benign parotid tumors. The magnified endoscopic view may facilitate more precise dissection and improved identification of facial nerve branches while allowing smaller incisions and potentially better cosmetic outcomes .
Despite encouraging results reported in several studies, the available evidence comparing endoscopic parotidectomy with the conventional approach remains limited. Therefore, further prospective comparative studies are required to evaluate the safety, efficacy, and cosmetic advantages of this minimally invasive technique.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Asyut, Egypt, 2063045
- Department of General Surgery, Maxillofacial and Head and Neck Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Patients with benign parotid tumors involving the superficial lobe of the parotid gland
- Tumors located in the inferior pole with or without limited deep lobe extension
- Tumor size suitable for minimally invasive approach ≤4 cm
- Patients fit for surgery under general anesthesia
- Patients willing to provide informed consent and comply with follow-up
Exclusion Criteria:
- Recurrent parotid tumors
- Previous parotid surgery on the affected side
- Pre-existing facial nerve dysfunction
- Previous neck surgery or extensive cervical/anterior chest wall scarring
- Significant comorbidities contraindicating surgery or general anesthesia
- Suspected or confirmed malignant parotid tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endoscopic Parotidectomy Group
Experimental Arm Endoscopic Parotidectomy
|
Minimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors.
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Active Comparator: Conventional Open Parotidectomy Group
Conventional Parotidectomy
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Conventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical safety and feasibility
Time Frame: During surgery and up to 3 months postoperatively.
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Assessment of intraoperative and postoperative complications and conversion rate to open surgery.
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During surgery and up to 3 months postoperatively.
|
|
Facial nerve function
Time Frame: 24 hours, 1 week, 1 month, and 3 months postoperatively.
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Assessment using House-Brackmann grading system.
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24 hours, 1 week, 1 month, and 3 months postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intraoperative blood loss
Time Frame: Intraoperative
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Intraoperative
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- endo-parotidectomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parotidectomy
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University of Wisconsin, MadisonRecruiting
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University of British ColumbiaUnknown
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Al-Azhar UniversityCompletedParotidectomy | Parotid TumorsEgypt
Clinical Trials on Endoscopic Parotidectomy Group
-
Mansoura UniversityWithdrawn
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Al-Azhar UniversityCompletedParotidectomy | Parotid TumorsEgypt
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Liaquat University of Medical & Health SciencesCompletedAdenoma, Pleomorphic | Facial Nerve InjuriesPakistan
-
Domain Surgical, Inc.Completed
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Kafrelsheikh UniversityFayoum UniversityCompletedSurgery | Parotid Tumor | Parotid Neoplasms | Head and Neck DisorderEgypt
-
Fundacion Miguel ServetRecruiting
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Command Hospital, IndiaUnknown
-
St. Luke's-Roosevelt Hospital CenterWithdrawnAppendicitis | Pelvic Pain | GallstonesUnited States
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Massachusetts General HospitalCompleted
-
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