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Search / Trial NCT06965738

Buccal Fat for Transoral Robotic Lateral Oropharyngectomy Defects to and Postoperative Pain

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · May 1, 2025

Trial Information

Current as of November 11, 2025

Not yet recruiting

Keywords

Transoral Robotic Surgery Buccal Fat Postoperative Pain

ClinConnect Summary

This clinical trial is looking at how a specific type of fat, called buccal fat, can help reduce pain after surgery for tonsil tumors. The main focus is on patients who need a special surgery called transoral robotic surgery, which is a less invasive way to remove tumors from the throat. Researchers want to find out if using buccal fat during the surgery makes a difference in how much pain patients feel, both when they are resting and when they are swallowing. They will also look at other factors like how well patients can swallow, any complications that might arise, how much pain medication is needed, and whether feeding tubes are required.

To be eligible for this trial, participants must be over 18 years old and need to have surgery for early to intermediate-stage tonsil cancer or certain salivary gland tumors. They should be able to understand the trial and agree to participate. Patients with a history of specific head and neck cancers, certain health issues, or those who are pregnant are not eligible. If you join the trial, you will rate your pain and swallowing abilities after the surgery, and the results will help determine if buccal fat is beneficial for reducing post-surgical discomfort. The trial is not yet recruiting participants, but it aims to provide important insights into improving recovery for patients undergoing this type of surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age \> 18
  • 2. 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
  • 3. Ability to understand and willing to sign a written informed consent
  • Exclusion Criteria:
  • 1. History of prior head and neck squamous cell carcinoma, or prior head and neck radiotherapy
  • 2. Presence of retropharyngeal lymphadenopathy
  • 3. Presence of bilateral lymphadenopathy, or patients requiring bilateral neck dissections.
  • 4. Patients with trismus at baseline
  • 5. Patients with psychological risk factors for persistent opioid use or drug addiction
  • 6. Need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap.
  • 7. Pregnancy

About University Health Network, Toronto

University Health Network (UHN), based in Toronto, is a leading academic health sciences center dedicated to advancing patient care through innovative research and education. As a prominent sponsor of clinical trials, UHN integrates cutting-edge scientific discoveries with clinical practice, facilitating the development of new therapies and treatment modalities. With a commitment to improving health outcomes, UHN collaborates with a diverse network of researchers, healthcare professionals, and industry partners, fostering an environment that prioritizes patient safety and ethical standards in clinical research. Through its extensive resources and expertise, UHN plays a pivotal role in transforming healthcare and enhancing the quality of life for patients both locally and globally.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Christopher Yao, MD FRCSC

Principal Investigator

University Health Network, Toronto

John R de Almeida, MD MSc FRCSC

Study Director

University Health Network, Toronto

Michael Xie, MD FRCSC

Study Chair

University Health Network, Toronto

Rosemary Martino, Ma MSc PhD

Study Chair

University Health Network, Toronto

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported