PURPOSE:Vocal fold medialization laryngoplasty (ML) and laryngeal reinnervation (LR) as treatments for unilateral vocal fold paralysis (UVFP) were compared in a multicenter, prospective, randomized clinical trial. METHODS:Previously untreated patients with UVFP were randomized to undergo either ML or LR. Voice results were compared pretreatment and at 6 and 12 months posttreatment using perceptual ratings by untrained listeners (RUL), blinded speech pathologist GRBAS scores, and voice-related quality of life (VRQOL) scores. Other secondary data included maximum phonation time (MPT), cepstral analysis, and electromyography (EMG) findings. RESULTS:Twenty-four patients from nine sites completed the study, 12 in each group. There were no significant intergroup differences in pretreatment variables. At 12 months, both study groups showed significant improvement in RUL, total GRBAS (grade, roughness, breathiness, asthenia, and strain) scores, and VRQOL scores, but no significant differences were found between the two groups. However, patient age significantly affected the LR, but not the ML, group results. The age less than 52 LR subgroup had significantly (P < .05) better scores than the age more than 52 LR subgroup, and had better RUL and GRBAS scores than the age less than 52 ML subgroup. The age more than 52 ML subgroup results were significantly better than the age more than 52 LR subgroup. The secondary data generally followed the primary data, except that the MPTs for the ML patients were significantly longer than for the LR patients. CONCLUSIONS: ML and LR are both effective surgical options for patients with UVFP. Laryngeal reinnervation should be considered in younger patients, whereas medialization laryngoplasty should be favored in older patients.
RCT Entities:
PURPOSE: Vocal fold medialization laryngoplasty (ML) and laryngeal reinnervation (LR) as treatments for unilateral vocal fold paralysis (UVFP) were compared in a multicenter, prospective, randomized clinical trial. METHODS: Previously untreated patients with UVFP were randomized to undergo either ML or LR. Voice results were compared pretreatment and at 6 and 12 months posttreatment using perceptual ratings by untrained listeners (RUL), blinded speech pathologist GRBAS scores, and voice-related quality of life (VRQOL) scores. Other secondary data included maximum phonation time (MPT), cepstral analysis, and electromyography (EMG) findings. RESULTS: Twenty-four patients from nine sites completed the study, 12 in each group. There were no significant intergroup differences in pretreatment variables. At 12 months, both study groups showed significant improvement in RUL, total GRBAS (grade, roughness, breathiness, asthenia, and strain) scores, and VRQOL scores, but no significant differences were found between the two groups. However, patient age significantly affected the LR, but not the ML, group results. The age less than 52 LR subgroup had significantly (P < .05) better scores than the age more than 52 LR subgroup, and had better RUL and GRBAS scores than the age less than 52 ML subgroup. The age more than 52 ML subgroup results were significantly better than the age more than 52 LR subgroup. The secondary data generally followed the primary data, except that the MPTs for the MLpatients were significantly longer than for the LRpatients. CONCLUSIONS:ML and LR are both effective surgical options for patients with UVFP. Laryngeal reinnervation should be considered in younger patients, whereas medialization laryngoplasty should be favored in older patients.
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