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NOT YET RECRUITING
NCT06965738
PHASE2

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-06-01

Completion Date

2027-05-01

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

PROCEDURE

Buccal fat reconstruction

Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

PROCEDURE

No buccal fat reconstruction

No reconstruction of lateral oropharyngectomy defect

Locations (1)

Toronto General Hospital

Toronto, Ontario, Canada