Clinical Trial

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

Study acronym: BOLT
Not Yet Recruiting Phase 2
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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 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-01.
Trial Details
NCT Number NCT06965738
Lead Sponsor University Health Network, Toronto
Conditions Tonsil Neoplasm, Oropharynx Neoplasm, Transoral Robotic Surgery
Enrollment 40 participants
Start Date 2025-06-01
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-21