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Lack of enrollment of eligible patients for randomization.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrant parotidectomy | Experimental | Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor |
|
| Superficial parotidectomy | Active Comparator | Patients in this group will receive superficial parotidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrant parotidectomy | Procedure | Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with permanent facial nerve palsy | using clinical neurological examination | measured six months after the date of surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama Hussein, MD, PhD | Mansoura University | Principal Investigator |
| Adel Denewer, MD | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Cancer Center | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21417969 | Background | Uyar Y, Caglak F, Keles B, Yildirim G, Salturk Z. Extracapsular dissection versus superficial parotidectomy in pleomorphic adenomas of the parotid gland. Kulak Burun Bogaz Ihtis Derg. 2011 Mar-Apr;21(2):76-9. doi: 10.5606/kbbihtisas.2011.003. | |
| 1328626 | Background | Prichard AJ, Barton RP, Narula AA. Complications of superficial parotidectomy versus extracapsular lumpectomy in the treatment of benign parotid lesions. J R Coll Surg Edinb. 1992 Jun;37(3):155-8. |
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| Superficial parotidectomy | Procedure | Excision of the whole superficial lobe of the parotid gland |
|
| Measured at the time of surgery |