BOLT
Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)
Sponsor study identifier
interventional
40
1 country
1
Study Start
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2025
Actual (reported)May 11, 2025
Actual (reported)June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative pain during rest and swallowing
Postoperative pain during rest and swallowing on visual analogue scale at multiple time points
Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28
Surgical Complications
30 days postoperatively
Opioid usage
30 days postoperatively
Postoperative Hemorrhage
30 days postoperatively
Speech and Swallowing
Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Oral Diet
Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Transoral lateral oropharyngectomy without buccal fat reconstruction
Transoral lateral oropharyngectomy with buccal fat reconstruction
Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect
No reconstruction of lateral oropharyngectomy defect
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Xie M, de Almeida J, Goldstein D, Martino R, Liu YF, Allen B, Xu W, Hueniken K, Yao CM. Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol. BMJ Open. 2025 Dec 12;15(12):e106125. doi: 10.1136/bmjopen-2025-106125.
Christopher Yao, MD FRCSC
University Health Network, Toronto
John R de Almeida, MD MSc FRCSC
University Health Network, Toronto
Michael Xie, MD FRCSC
University Health Network, Toronto
Rosemary Martino, Ma MSc PhD
University Health Network, Toronto
First Submitted
March 31, 2025
First Posted
May 11, 2025
Study Start
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2027
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 21, 2025
Record last verified: 2025-05
De-identified data, randomization, primary and secondary outcomes
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Source: ClinicalTrials.gov.
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