Status:
NOT_YET_RECRUITING
Buccal Fat for Transoral Robotic Lateral Oropharyngectomy Defects to and Postoperative Pain
Lead Sponsor:
University Health Network, Toronto
Conditions:
Tonsil Neoplasm
Oropharynx Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this randomized clinical trial is to determine the pain intensity during rest and swallowing in patients undergoing transoral robotic surgery for tonsil lesions with and without buccal fat...
Detailed Description
Trans-oral robotic surgery (TORS) for oropharyngeal cancers have transformed how oropharyngeal cancers are managed, allowing for minimally invasive surgical access to remove tumors of the tonsil and b...
Eligibility Criteria
Inclusion
- Age \> 18
- Require a transoral robotic lateral oropharyngectomy as a result of the following conditions :
- Early - intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/- SCC of the palatine tonsils)
- Early -intermediate stage salivary gland tumors of the palatine tonsils
- based on FNA, Core biopsy, Punch biopsy
- Ability to understand and willing to sign a written informed consent
Exclusion
- History of prior head and neck squamous cell carcinoma, or prior head and neck radiotherapy
- Presence of retropharyngeal lymphadenopathy
- Presence of bilateral lymphadenopathy, or patients requiring bilateral neck dissections.
- Patients with trismus at baseline
- Patients with psychological risk factors for persistent opioid use or drug addiction
- Need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap.
- Pregnancy
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06965738
Start Date
June 1 2025
End Date
May 1 2027
Last Update
May 21 2025
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4