Quadrant Versus Superficial Parotidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01607866
Recruitment Status : Withdrawn (Lack of enrollment of eligible patients for randomization.)
First Posted : May 30, 2012
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Osama Hussein, Mansoura University

May 24, 2012
May 30, 2012
November 8, 2016
June 2014
July 2016   (Final data collection date for primary outcome measure)
Number of participants with permanent facial nerve palsy [ Time Frame: measured six months after the date of surgery ]
using clinical neurological examination
Incidence of facial nerve palsy [ Time Frame: at six months after surgery ]
using clinical neurological examination
Complete list of historical versions of study NCT01607866 on Archive Site
  • 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
  • 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
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Quadrant Versus Superficial Parotidectomy
Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
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.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Pleomorphic Adenoma of the Parotid Gland
  • Procedure: Quadrant parotidectomy
    Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland
  • Procedure: Superficial parotidectomy
    Excision of the whole superficial lobe of the parotid gland
  • Experimental: Quadrant parotidectomy
    Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor
    Intervention: Procedure: Quadrant parotidectomy
  • Active Comparator: Superficial parotidectomy
    Patients in this group will receive superficial parotidectomy
    Intervention: Procedure: Superficial parotidectomy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2016
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Osama Hussein, Mansoura University
Mansoura University
Not Provided
Principal Investigator: Osama Hussein, MD, PhD Mansoura University
Study Chair: Adel Denewer, MD Mansoura University
Mansoura University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP