Clinical Trial: Quadrant Versus Superficial Parotidectomy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Mansoura University

Current Primary Outcome: Number of participants with permanent facial nerve palsy [ Time Frame: measured six months after the date of surgery ]

using clinical neurological examination


Original Primary Outcome: Incidence of facial nerve palsy [ Time Frame: at six months after surgery ]

using clinical neurological examination


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Temporary facial nerve palsy [ Time Frame: at three months after surgery. ]
    using clinical neurological examination
  • Cosmetic results [ Time Frame: at three weeks after surgery ]
    The patient subjective cosmetic scoring and an objective observer cosmetic score will be recorded for each patient to evaluate the appearance of the parotid area after surgery
  • Operative timing [ Time Frame: at the date of surgery ]
    Median and range of operative time per intervention arm willl be recorded
  • Temporary facial nerve palsy [ Time Frame: at day one after surgery ]
    using clinical neurological examination


Information By: Mansoura University

Dates:
Date Received: May 24, 2012
Date Started: June 2014
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016