Quadrant Versus Superficial Parotidectomy

NCT01607866 | Withdrawn Phase 2

• 1 other identifier: R/89
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleomorphic Adenoma of the Parotid Gland

Outcome Measures

Primary Outcomes (1)

• Number of participants with permanent facial nerve palsy

  using clinical neurological examination

  measured six months after the date of surgery

Secondary Outcomes (2)

• Number of participants with temporary facial nerve palsy

  Measured at one day and at three months from the date of surgery.

• Operative time in minutes

  Measured at the time of surgery

Study Arms (2)

Quadrant parotidectomy

EXPERIMENTAL

Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor

Procedure: Quadrant parotidectomy

Superficial parotidectomy

ACTIVE COMPARATOR

Patients in this group will receive superficial parotidectomy

Procedure: Superficial parotidectomy

Interventions

Quadrant parotidectomy PROCEDURE

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

Quadrant parotidectomy

Superficial parotidectomy PROCEDURE

Excision of the whole superficial lobe of the parotid gland

Superficial parotidectomy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis

You may not qualify if:

• Collagen diseases
• Previous parotid surgery
• Previous facial nerve palsy
• Neuromuscular diseases affecting the face
• Patient refusal

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Cancer Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (2)

• Uyar Y, Caglak F, Keles B, Yildirim G, Salturk Z. Extracapsular dissection versus superficial parotidectomy in pleomorphic adenomas of the parotid gland. Kulak Burun Bogaz Ihtis Derg. 2011 Mar-Apr;21(2):76-9. doi: 10.5606/kbbihtisas.2011.003.

  PMID: 21417969 BACKGROUND

• Prichard AJ, Barton RP, Narula AA. Complications of superficial parotidectomy versus extracapsular lumpectomy in the treatment of benign parotid lesions. J R Coll Surg Edinb. 1992 Jun;37(3):155-8.

  PMID: 1328626 BACKGROUND

Study Officials

• Osama Hussein, MD, PhD

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Adel Denewer, MD

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

EG (1)