OBJECTIVE: To conduct a prospective randomized controlled trial describing and investigating the efficacy and safety of radiosurgical excision of benign superficial vocal fold lesions. MATERIALS AND METHODS:Fifty patients with benign superficial vocal fold lesions (20 vocal nodules, 27 vocal polyps and three Reinke's oedema) who failed conservative therapy were included in the study. They were equally randomized into cold knife or radiosurgical excision. Clinical and voice assessments were done pre-operatively and after surgery. Voice analysis included a subjective visual analogue scale (VAS) and a perceptual assessment with a simplified version of the GRBAS scale (GRB) consisting of G (grade), R (roughness), and B (breathiness). Acoustic voice evaluation included jitter and shimmer. Post-operative voice therapy was provided for all patients. Complications, smoothness of post-operative recovery, and administration of analgesia were reported. RESULTS: Both groups experienced significant improvement in VAS, perceptual evaluation and acoustic analysis after surgery, with no evidence of significant differences between the cold knife and radiofrequency groups. The radiofrequency group showed a decrease of 17 per cent in the mean operative time when compared with the cold knife group, but this was not statistically significant. No evidence of a significant difference was noticed in the smoothness of post-operative recovery, administration of analgesia and complication rate. CONCLUSION:Radiophonosurgery opens a new therapeutic approach for patients with benign superficial vocal fold lesions. It combines the advantages of both cold knife and laser phonosurgery, being easy, safe, precise and effective, and having excellent tactile and haemostatic properties.
RCT Entities:
OBJECTIVE: To conduct a prospective randomized controlled trial describing and investigating the efficacy and safety of radiosurgical excision of benign superficial vocal fold lesions. MATERIALS AND METHODS: Fifty patients with benign superficial vocal fold lesions (20 vocal nodules, 27 vocal polyps and three Reinke's oedema) who failed conservative therapy were included in the study. They were equally randomized into cold knife or radiosurgical excision. Clinical and voice assessments were done pre-operatively and after surgery. Voice analysis included a subjective visual analogue scale (VAS) and a perceptual assessment with a simplified version of the GRBAS scale (GRB) consisting of G (grade), R (roughness), and B (breathiness). Acoustic voice evaluation included jitter and shimmer. Post-operative voice therapy was provided for all patients. Complications, smoothness of post-operative recovery, and administration of analgesia were reported. RESULTS: Both groups experienced significant improvement in VAS, perceptual evaluation and acoustic analysis after surgery, with no evidence of significant differences between the cold knife and radiofrequency groups. The radiofrequency group showed a decrease of 17 per cent in the mean operative time when compared with the cold knife group, but this was not statistically significant. No evidence of a significant difference was noticed in the smoothness of post-operative recovery, administration of analgesia and complication rate. CONCLUSION: Radiophonosurgery opens a new therapeutic approach for patients with benign superficial vocal fold lesions. It combines the advantages of both cold knife and laser phonosurgery, being easy, safe, precise and effective, and having excellent tactile and haemostatic properties.