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

NCT06965738 | Not Yet Recruiting Phase 2

• 1 other identifier: 24-5894
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tonsil Neoplasm; Oropharynx Neoplasm; Transoral Robotic Surgery

Keywords

Transoral Robotic Surgery; Buccal Fat; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

Transoral lateral oropharyngectomy alone

ACTIVE COMPARATOR

Transoral lateral oropharyngectomy without buccal fat reconstruction

Procedure: No buccal fat reconstruction

Transoral lateral oropharyngectomy with buccal fat reconstruction

EXPERIMENTAL

Transoral lateral oropharyngectomy with buccal fat reconstruction

Procedure: Buccal fat reconstruction

Interventions

Buccal fat reconstruction PROCEDURE

Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

Transoral lateral oropharyngectomy with buccal fat reconstruction

No buccal fat reconstruction PROCEDURE

No reconstruction of lateral oropharyngectomy defect

Transoral lateral oropharyngectomy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• 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
• Ability to understand and willing to sign a written informed consent

You may not qualify if:

• 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
• Patients with psychological risk factors for persistent opioid use or drug addiction
• Need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap.
• Pregnancy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 41387003 DERIVED

MeSH Terms

Conditions

Tonsillar Neoplasms; Oropharyngeal Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Christopher Yao, MD FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• John R de Almeida, MD MSc FRCSC

  University Health Network, Toronto

  STUDY DIRECTOR

• Michael Xie, MD FRCSC

  University Health Network, Toronto

  STUDY CHAIR

• Rosemary Martino, Ma MSc PhD

  University Health Network, Toronto

  STUDY CHAIR

Central Study Contacts

Christopher Yao, MD FRCSC

CONTACT

(416) 340-3063; christophermkl.yao@uhn.ca

Michael Xie, MD FRCSC

CONTACT

(416) 340-3063; michael.xie@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: May 2027-May 2037
• Access Criteria: IPD can be shared on a case by case basis by contacting the principal investigator, data will be de-identified, extent of data will be determined and decided upon by the principal investigator, data will be shared via secure email and data transfer agreement

Locations

CA (1)