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Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma


Phase 2/Phase 3
20 Years
70 Years
Not Enrolling
Both
Pleomorphic Adenoma of the Parotid Gland

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Trial Information

Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Incidence of facial nerve palsy

Outcome Description:

using clinical neurological examination

Outcome Time Frame:

at six months after surgery

Safety Issue:

No

Principal Investigator

Osama Hussein, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mansoura University

Authority:

Egypt: Ministry of Higher Education

Study ID:

000

NCT ID:

NCT01607866

Start Date:

September 2012

Completion Date:

February 2016

Related Keywords:

  • Pleomorphic Adenoma of the Parotid Gland
  • Adenoma
  • Adenoma, Pleomorphic

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