ParotidectomyminiparoNCT07600112
Endoscopic Versus Conventional Parotidectomy for Benign Parotid Tumors
A study testing Endoscopic Parotidectomy Group and Active Comparator Intervention Conventional Parotidectomy in people with Parotidectomy, run by Assiut University at 1 site in Egypt.
Trial summary
To compare endoscopic and conventional parotidectomy in the management of benign parotid tumors regarding surgical outcomes, facial nerve preservation, operative time, postoperative complications, and cosmetic results, in order to evaluate the safety, feasibility, and potential advantages of the endoscopic minimally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotidectomy
- What is being tested?
- Endoscopic Parotidectomy Group and Active Comparator Intervention Conventional Parotidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of General Surgery, Maxillofacial and Head and Neck Unit
Asyut, 2063045
About this study
Official title: Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study
To compare endoscopic and conventional parotidectomy in the management of benign parotid tumors regarding surgical outcomes, facial nerve preservation, operative time, postoperative complications, and cosmetic results, in order to evaluate the safety, feasibility, and potential advantages of the endoscopic minimally invasive technique.
Read the 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.
- Conditions
- Parotidectomy
- Being tested
- Endoscopic Parotidectomy Group, Active Comparator Intervention Conventional Parotidectomy
- Keywords
- parotidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Parotidectomy GroupProcedure or surgery
Minimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors.
Active Comparator Intervention Conventional ParotidectomyProcedure or surgery
Conventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Parotidectomy Group | Experimental | Experimental Arm Endoscopic Parotidectomy Receives: Procedure: Endoscopic Parotidectomy Group |
| Conventional Open Parotidectomy Group | Active comparator | Conventional Parotidectomy Receives: Procedure: Active Comparator Intervention Conventional Parotidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical safety and feasibility
Assessment of intraoperative and postoperative complications and conversion rate to open surgery.
Measured: During surgery and up to 3 months postoperatively.
Facial nerve function
Assessment using House-Brackmann grading system.
Measured: 24 hours, 1 week, 1 month, and 3 months postoperatively.
Secondary outcomes (1)
Intraoperative blood loss
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 May 2026
- Primary completion29 Dec 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParotidectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled parallel assignment
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Hussein Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600112
- Sponsor's protocol ID
- endo-parotidectomy
- Acronym
- miniparo
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available. De-identified data may be available from the principal investigator upon reasonable academic request and after approval by the Institutional Review Board.
Publications
O'Brien CJ. Current management of benign parotid tumors--the role of limited superficial parotidectomy. Head Neck. 2003 Nov;25(11):946-52. doi: 10.1002/hed.10312.
PubMed 14603455
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07600112
- Acronym / sponsor ID
- miniparo / endo-parotidectomy
- Conditions
- Parotidectomy
- Keywords
- parotidectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare endoscopic and conventional parotidectomy in the management of benign parotid tumors regarding surgical outcomes, facial nerve preservation, operative time, postoperative complications, and cosmetic results, in order to evaluate the safety, feasibility, and potential advantages of the endoscopic minimally invasive technique.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Parotidectomy Group | Experimental | Procedure: Endoscopic Parotidectomy GroupExperimental Arm Endoscopic Parotidectomy |
| Conventional Open Parotidectomy Group | Active comparator | Procedure: Active Comparator Intervention Conventional ParotidectomyConventional Parotidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Parotidectomy GroupMinimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors. | Procedure or surgery | Endoscopic Parotidectomy Group |
| Active Comparator Intervention Conventional ParotidectomyConventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors. | Procedure or surgery | Conventional Open Parotidectomy Group |
Primary outcome
Surgical safety and feasibility
Time frame: During surgery and up to 3 months postoperatively.
Assessment of intraoperative and postoperative complications and conversion rate to open surgery.
Facial nerve function
Time frame: 24 hours, 1 week, 1 month, and 3 months postoperatively.
Assessment using House-Brackmann grading system.
1 secondary outcome
Intraoperative blood loss
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 14603455O'Brien CJ. Current management of benign parotid tumors--the role of limited superficial parotidectomy. Head Neck. 2003 Nov;25(11):946-52. doi: 10.1002/hed.10312.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available. De-identified data may be available from the principal investigator upon reasonable academic request and after approval by the Institutional Review Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Parotidectomy Group and Active Comparator Intervention Conventional Parotidectomy in people with Parotidectomy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical safety and feasibility (time frame: During surgery and up to 3 months postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07600112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.