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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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 reconstruction. The main question it aims to answer is: does buccal fat after transoral robotic surgery reduce pain after surgery? Additional questions to be explored include if there is a difference in swallowing, complication rates, pain medication usage, and feeding tube usage. Participants will be asked to rate their pain and swallowing on a visual analogue scale after surgery. The group will be compared compared to a control group that undergoes transoral robotic surgery without buccal fat reconstruction.

Eligibility criteria

Qualifiers

Age > 18

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Buccal fat reconstruction
  • No buccal fat reconstruction

Treatment groups

40 Participants
are divided into 2 treatment groups