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

NCT06965738 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

  • Tonsil Neoplasm
  • Oropharynx Neoplasm
  • Transoral Robotic Surgery

Interventions

PROCEDURE

Buccal fat reconstruction

Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

PROCEDURE

No buccal fat reconstruction

No reconstruction of lateral oropharyngectomy defect

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Christopher Yao, MD FRCSC · University Health Network, Toronto

  • John R de Almeida, MD MSc FRCSC · University Health Network, Toronto

  • Michael Xie, MD FRCSC · University Health Network, Toronto

  • Rosemary Martino, Ma MSc PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-04-01
Completion
2027-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965738 on ClinicalTrials.gov