OBJECTIVES: To conduct the first prospective randomized controlled trial that evaluates and compares the clinical outcome and impact of ballonsinuplasty and endoscopic sinus surgery (ESS) on the quality of life of patients suffering from chronic or recurrent rhinosinusitis (CRS) of the maxillary sinus. METHODS:Adult patients with symptomatic chronic or recurrent rhinosinusitis without severe findings in the sinuses, as documented in the sinus’ Computer Tomography scan and clinical exam, were randomized in 2 groups: ESS and Balloon Sinuplasty.The main variable in our study is the Sinonasal Outcome Test-22 (SNOT 22) and its parameters. These parameters were analysed preoperatively and at 3 months, postoperatively. RESULTS: There was a subjective improvement in symptoms after surgery. We also noticed an objective improvement in the quality of life of our patients seen as a decrease in the total SNOT 22 score. Both balloon sinuplasty and ESS significantly improved almost all the parameters of SNOT22, with no significant difference being found between these two groups. CONCLUSION: Both balloon sinuplasty and endoscopic sinus surgery improved the quality of life of patients with mild chronic or recurrent rhinosinusitis. However, the remarkably higher material cost of balloon sinuplasty compared to ESS sets limits on its broad use. There is an obvious need for further study to find out if, as an office procedure, balloon sinuplasty could deliver cost-savings high enough to cover the higher material cost of balloon sinuplasty. Our study was, however, too small to enable firm conclusions to be drawn.
RCT Entities:
OBJECTIVES: To conduct the first prospective randomized controlled trial that evaluates and compares the clinical outcome and impact of ballonsinuplasty and endoscopic sinus surgery (ESS) on the quality of life of patients suffering from chronic or recurrent rhinosinusitis (CRS) of the maxillary sinus. METHODS: Adult patients with symptomatic chronic or recurrent rhinosinusitis without severe findings in the sinuses, as documented in the sinus’ Computer Tomography scan and clinical exam, were randomized in 2 groups: ESS and Balloon Sinuplasty.The main variable in our study is the Sinonasal Outcome Test-22 (SNOT 22) and its parameters. These parameters were analysed preoperatively and at 3 months, postoperatively. RESULTS: There was a subjective improvement in symptoms after surgery. We also noticed an objective improvement in the quality of life of our patients seen as a decrease in the total SNOT 22 score. Both balloon sinuplasty and ESS significantly improved almost all the parameters of SNOT22, with no significant difference being found between these two groups. CONCLUSION: Both balloon sinuplasty and endoscopic sinus surgery improved the quality of life of patients with mild chronic or recurrent rhinosinusitis. However, the remarkably higher material cost of balloon sinuplasty compared to ESS sets limits on its broad use. There is an obvious need for further study to find out if, as an office procedure, balloon sinuplasty could deliver cost-savings high enough to cover the higher material cost of balloon sinuplasty. Our study was, however, too small to enable firm conclusions to be drawn.