Clinical trial · Interventional
Buccal Fat for Transoral Robotic Lateral Oropharyngectomy Defects to and Postoperative Pain
Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharynx Neoplasm | — | UNRESOLVED | — |
| Tonsil Neoplasm | Tonsillar Neoplasm | ALIAS | 0.90 |
| Transoral Robotic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buccal fat reconstruction | Procedure | — | UNRESOLVED |
| No buccal fat reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transoral lateral oropharyngectomy alone
- description
- Transoral lateral oropharyngectomy without buccal fat reconstruction
- interventionNames
- Procedure: No buccal fat reconstruction
- type
- EXPERIMENTAL
- label
- Transoral lateral oropharyngectomy with buccal fat reconstruction
- description
- Transoral lateral oropharyngectomy with buccal fat reconstruction
- interventionNames
- Procedure: Buccal fat reconstruction
Primary outcomes (1)
- measure
- Postoperative pain during rest and swallowing
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDXie 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