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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)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965738
Acronym
BOLT
Enrollment
40
Registered
2025-05-11
Start date
2025-06-01
Completion date
2027-05-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharynx Neoplasm, Tonsil Neoplasm, Transoral Robotic Surgery

Keywords

Transoral Robotic Surgery, Buccal Fat, Postoperative Pain

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.

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.

Interventions

PROCEDUREBuccal fat reconstruction

Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

PROCEDURENo buccal fat reconstruction

No reconstruction of lateral oropharyngectomy defect

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain during rest and swallowingOnce each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28Postoperative pain during rest and swallowing on visual analogue scale at multiple time points

Secondary

MeasureTime frameDescription
Opioid usage30 days postoperativelyDetermine opioid usage
Postoperative Hemorrhage30 days postoperativelyPostoperative hemorrhage after TORS
Speech and SwallowingOnce each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28Determine postoperative speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN)
Surgical Complications30 days postoperativelySurgical complications and adverse events within 30 days postoperatively using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC-AE v4.0)
Feeding Tube Placement30 days postoperativelyDetermine rate of feeding tube placement
Blood Glucose30 days postoperativelyDetermine blood glucose levels
Oral DietOnce each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28Determine food consistencies achieved at short post-operative follow up (per PSS-HN)

Countries

Canada

Contacts

Primary ContactChristopher Yao, MD FRCSC
christophermkl.yao@uhn.ca(416) 340-3063
Backup ContactMichael Xie, MD FRCSC
michael.xie@uhn.ca(416) 340-3063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026