Quadrant Versus Superficial Parotidectomy

Study Overview
=================
Brief Summary
-----------------
The most common benign tumor of the parotid gland is the so called pleomorphic adenoma. Although benign, this tumor may recur after surgical removal due to tumor cells left behind during the surgical operation. Thus, pleomorphic adenomas have been treated with wide resection similar to malignant tumors. This extensive surgery often leads to injury to the motor nerves responsible for facial expression and eye protection. The investigators propose less extensive surgery which should be thorough enough to prevent tumor recurrence while keeping the facial nerve out of risk.

Detailed Description
-----------------
Pleomorphic adenoma is notorious of its propensity to local recurrence due to the microscopic extracapsular extension of the tumor. Superficial parotidectomy (SP) is the standard treatment. Extracapsular dissection (ED) has been proposed to minimize the risk of facial nerve palsy. However, the oncologic safety of ED is controversial in the literature. We propose quadrant parotidectomy (QP) which is less radical than SP and less conservative than ED. QP entails dissection overlying one primary division of the facial nerve leaving the other division undisturbed while the resection safety margin is still generous. Surgery for pleomorphic adenoma is a compromise between radicality and facial nerve morbidity. Risk of local recurrence is imprecisely described in the literature and is universally regarded as infrequent and remote. Many studies did not report recurrent cases. Thus, Facial nerve injury is the main concern of parotid surgeons and is considered the primary end point of this study.

Official Title
-----------------
Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma

Conditions
-----------------
Pleomorphic Adenoma of the Parotid Gland

Intervention / Treatment
-----------------
* Procedure: Quadrant parotidectomy
* Procedure: Superficial parotidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis Exclusion Criteria: Collagen diseases Previous parotid surgery Previous facial nerve palsy Neuromuscular diseases affecting the face Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadrant parotidectomy<br>Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor | Procedure: Quadrant parotidectomy<br>* Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland<br>|
| Active Comparator: Superficial parotidectomy<br>Patients in this group will receive superficial parotidectomy | Procedure: Superficial parotidectomy<br>* Excision of the whole superficial lobe of the parotid gland<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with permanent facial nerve palsy | using clinical neurological examination | measured six months after the date of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with temporary facial nerve palsy | using clinical neurological examination | Measured at one day and at three months from the date of surgery. | 
| Operative time in minutes | Median and range of operative time per intervention arm will be recorded | Measured at the time of surgery |