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Quadrant Versus Superficial Parotidectomy

M

Mansoura University

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Pleomorphic Adenoma of the Parotid Gland

Treatments

Procedure: Quadrant parotidectomy
Procedure: Superficial parotidectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Quadrant parotidectomy
Experimental group
Description:
Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor
Treatment:
Procedure: Quadrant parotidectomy
Superficial parotidectomy
Active Comparator group
Description:
Patients in this group will receive superficial parotidectomy
Treatment:
Procedure: Superficial parotidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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