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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tonsil Neoplasm; Oropharynx Neoplasm; Transoral Robotic Surgery
• Intervention / Treatment: Procedure: No buccal fat reconstruction; Procedure: Buccal fat reconstruction

Detailed Description

Trans-oral robotic surgery (TORS) for oropharyngeal cancers have transformed how oropharyngeal cancers are managed, allowing for minimally invasive surgical access to remove tumors of the tonsil and base of tongue. While large incisions and open approaches can be avoided, oropharyngeal defects following TORS are traditionally left as an open wound to heal by secondary intention, resulting in significant postoperative pain, and possibly dysphagia and dehydration.

While this has been highlighted as a key outcome measure, studies on acute pain following TORS have not had any standardization regarding the timing of pain measurement, and pain assessment. Only one study has assessed pain during 'movement-related pain', such as swallowing, which has been advocated as a key metric. Most studies used a visual analogue scale, however, majority failed to describe the timing of pain assessment relative to administration of analgesia, time of day, or diet. Overall, pain ratings and opioid utilization were highly variable between studies resulting in pain ratings ranging widely from 2.5-8 in the first few days postoperatively.

Based on the current evidence, multimodal analgesia resulted in the lowest pain ratings following TORS, with those that included gabapentin, a COX-2 inhibitor and acetaminophen having excellent pain control in the early postoperative period. Using these regimens, Castellanos et al. found that postoperative opioid consumption significantly decreased in the first three postoperative days. Clayburgh, et al. identified that addition of perioperative corticosteroids was safe and significantly improved diet consistency, and decreased length of hospital stay, though pain scores were minimally affected.

No study thus far has assessed the impact of surgical interventions on postoperative pain and swallowing. This single center, phase II, randomized control trial aims to evaluate the impact of the buccal fat rotational flap on the postoperative pain following TORS.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christopher Yao, MD FRCSC; Phone Number: (416) 340-3063; Email: christophermkl.yao@uhn.ca
• Study Contact Backup: Name: Michael Xie, MD FRCSC; Phone Number: (416) 340-3063; Email: michael.xie@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18

2. 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
3. Ability to understand and willing to sign a written informed consent

Exclusion Criteria:

1. History of prior head and neck squamous cell carcinoma, or prior head and neck radiotherapy
2. Presence of retropharyngeal lymphadenopathy
3. Presence of bilateral lymphadenopathy, or patients requiring bilateral neck dissections.
4. Patients with trismus at baseline
5. Patients with psychological risk factors for persistent opioid use or drug addiction
6. Need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap.
7. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transoral lateral oropharyngectomy alone; Transoral lateral oropharyngectomy without buccal fat reconstruction	Procedure: No buccal fat reconstruction; No reconstruction of lateral oropharyngectomy defect
Experimental: Transoral lateral oropharyngectomy with buccal fat reconstruction	Procedure: Buccal fat reconstruction; Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Complications	Surgical complications and adverse events within 30 days postoperatively using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC-AE v4.0)	30 days postoperatively
Opioid usage	Determine opioid usage	30 days postoperatively
Postoperative Hemorrhage	Postoperative hemorrhage after TORS	30 days postoperatively
Speech and Swallowing	Determine postoperative speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN)	Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Oral Diet	Determine food consistencies achieved at short post-operative follow up (per PSS-HN)	Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Feeding Tube Placement	Determine rate of feeding tube placement	30 days postoperatively
Blood Glucose	Determine blood glucose levels	30 days postoperatively

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Christopher Yao, MD FRCSC, University Health Network, Toronto; Study Director: John R de Almeida, MD MSc FRCSC, University Health Network, Toronto; Study Chair: Michael Xie, MD FRCSC, University Health Network, Toronto; Study Chair: Rosemary Martino, Ma MSc PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Transoral Robotic Surgery; Buccal Fat
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Neoplasms; Oropharyngeal Neoplasms; Tonsillar Neoplasms
• Other Study ID Numbers: 24-5894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data, randomization, primary and secondary outcomes
• IPD Sharing Time Frame: May 2027-May 2037
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No