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Quadrant Versus Superficial Parotidectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Osama Hussein, Mansoura University
ClinicalTrials.gov Identifier:
NCT01607866
First received: May 24, 2012
Last updated: June 22, 2014
Last verified: June 2014

May 24, 2012
June 22, 2014
June 2014
July 2017   (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 ] [ Designated as safety issue: No ]
using clinical neurological examination
Incidence of facial nerve palsy [ Time Frame: at six months after surgery ] [ Designated as safety issue: No ]
using clinical neurological examination
Complete list of historical versions of study NCT01607866 on ClinicalTrials.gov 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. ] [ Designated as safety issue: No ]
    using clinical neurological examination
  • Operative time in minutes [ Time Frame: Measured at the time of surgery ] [ Designated as safety issue: No ]
    Median and range of operative time per intervention arm will be recorded
  • Temporary facial nerve palsy [ Time Frame: at three months after surgery. ] [ Designated as safety issue: No ]
    using clinical neurological examination
  • Cosmetic results [ Time Frame: at three weeks after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Median and range of operative time per intervention arm willl be recorded
  • Temporary facial nerve palsy [ Time Frame: at day one after surgery ] [ Designated as safety issue: No ]
    using clinical neurological examination
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
December 2017
July 2017   (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
Both
20 Years to 70 Years
No
Contact: Osama Hussein, MD,PhD +201099815110 osama.hussein@mail.mcgill.ca
Contact: Adel Denewer, MD +201223237791 adeldenewer@mans.edu.eg
Egypt
 
NCT01607866
R/89
No
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
June 2014

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