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Quadrant Versus Superficial Parotidectomy

Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01607866
Enrollment
0
Registered
2012-05-30
Start date
2014-06-30
Completion date
2016-10-31
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleomorphic Adenoma of the Parotid Gland

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.

Interventions

PROCEDUREQuadrant parotidectomy

Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland

Excision of the whole superficial lobe of the parotid gland

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with permanent facial nerve palsymeasured six months after the date of surgeryusing clinical neurological examination

Secondary

MeasureTime frameDescription
Number of participants with temporary facial nerve palsyMeasured at one day and at three months from the date of surgery.using clinical neurological examination
Operative time in minutesMeasured at the time of surgeryMedian and range of operative time per intervention arm will be recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026