Health TrialsbyHealthPanel

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

ConditionsTonsil NeoplasmOropharynx NeoplasmTransoral Robotic Surgery
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Buccal fat reconstruction

    Procedure/Surgery

    Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

  • No buccal fat reconstruction

    Procedure/Surgery

    No reconstruction of lateral oropharyngectomy defect

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Transoral lateral oropharyngectomy aloneActive comparator 1 intervention
Group B: Transoral lateral oropharyngectomy with buccal fat reconstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain during rest and swallowing

Postoperative pain during rest and swallowing on visual analogue scale at multiple time points

Time frame
Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28

Secondary outcomes

1

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)

Time frame
30 days postoperatively
2

Opioid usage

Determine opioid usage

Time frame
30 days postoperatively
3

Postoperative Hemorrhage

Postoperative hemorrhage after TORS

Time frame
30 days postoperatively
4

Speech and Swallowing

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: