NCT07600112

Brief Summary

To compare endoscopic and conventional parotidectomy in the management of benign parotid tumors regarding surgical outcomes, facial nerve preservation, operative time, postoperative complications, and cosmetic results, in order to evaluate the safety, feasibility, and potential advantages of the endoscopic minimally invasive technique.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jun 2028

Study Start

First participant enrolled

May 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

parotidectomy

Outcome Measures

Primary Outcomes (2)

  • Surgical safety and feasibility

    Assessment of intraoperative and postoperative complications and conversion rate to open surgery.

    During surgery and up to 3 months postoperatively.

  • Facial nerve function

    Assessment using House-Brackmann grading system.

    24 hours, 1 week, 1 month, and 3 months postoperatively.

Secondary Outcomes (1)

  • Intraoperative blood loss

    Intraoperative

Study Arms (2)

Endoscopic Parotidectomy Group

EXPERIMENTAL

Experimental Arm Endoscopic Parotidectomy

Procedure: Endoscopic Parotidectomy Group

Conventional Open Parotidectomy Group

ACTIVE COMPARATOR

Conventional Parotidectomy

Procedure: Active Comparator Intervention Conventional Parotidectomy

Interventions

Minimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors.

Endoscopic Parotidectomy Group

Conventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors.

Conventional Open Parotidectomy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Patients with benign parotid tumors involving the superficial lobe of the parotid gland
  • Tumors located in the inferior pole with or without limited deep lobe extension
  • Tumor size suitable for minimally invasive approach ≤4 cm
  • Patients fit for surgery under general anesthesia
  • Patients willing to provide informed consent and comply with follow-up

You may not qualify if:

  • Recurrent parotid tumors
  • Previous parotid surgery on the affected side
  • Pre-existing facial nerve dysfunction
  • Previous neck surgery or extensive cervical/anterior chest wall scarring
  • Significant comorbidities contraindicating surgery or general anesthesia
  • Suspected or confirmed malignant parotid tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Maxillofacial and Head and Neck Unit

Asyut, 2063045, Egypt

Location

Related Publications (1)

  • O'Brien CJ. Current management of benign parotid tumors--the role of limited superficial parotidectomy. Head Neck. 2003 Nov;25(11):946-52. doi: 10.1002/hed.10312.

    PMID: 14603455BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized controlled parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly available. De-identified data may be available from the principal investigator upon reasonable academic request and after approval by the Institutional Review Board.

Locations