Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
NCT Number: NCT06965738
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Toronto, Ontario, M5G 2C4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect
No reconstruction of lateral oropharyngectomy defect
Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28
Postoperative pain during rest and swallowing on visual analogue scale at multiple time points
Time frame: 30 days postoperatively
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)
Time frame: 30 days postoperatively
Determine opioid usage
Time frame: 30 days postoperatively
Postoperative hemorrhage after TORS
Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Determine postoperative speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN)
Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
Determine food consistencies achieved at short post-operative follow up (per PSS-HN)
Time frame: 30 days postoperatively
Determine rate of feeding tube placement
Time frame: 30 days postoperatively
Determine blood glucose levels
Contact information is provided by the study sponsor or research team.
Christopher Yao, MD FRCSC
CONTACT
Michael Xie, MD FRCSC
CONTACT
University Health Network, Toronto
Other
Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)
Acronym: BOLT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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