Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer. Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
39
Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
Patients in the placebo group did not receive hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
Voice Outcome
Voice Handicap Index-10 Scores
Time frame: Change at 3 months post-operatively compared to baseline.
Voice Outcome
Voice Handicap Index-10 Scores
Time frame: Changes at 12 months post-operatively compared to baseline.
Voice Outcome
Voice Handicap Index-10 Scores
Time frame: Changes at 24 months post-operatively compared to baseline.
Voice Outcome
Maximum Phonation Time
Time frame: Changes at 3 months post-operatively compared to baseline.
Voice Outcome
Maximum Phonation Time
Time frame: Changes at 12 months post-operatively compared to baseline.
Voice Outcome
Maximum Phonation Time
Time frame: Changes at 24 months post-operatively compared to baseline.
Overall survival
Kaplan-Meier Survival Analysis
Time frame: 24 months post-augmentation
Disease free survival
Kaplan-Meier Survival Analysis
Time frame: 24 months post-augmentation
Recurrence-free survival
Kaplan-Meier Survival Analysis
Time frame: 24 months post-augmentation
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