Objectives: We sought to evaluate the effectiveness and safety of balloon dilation of the frontal recess in the management of chronic rhinosinusitis of the frontal sinus.
Methods: We designed a double-blind randomized clinical trial of functional endoscopic sinus surgery assisted by balloon dilation versus conventional functional endoscopic sinus surgery in the treatment of chronic rhinosinusitis of the frontal sinus. We enrolled a total of 40 patients in whom medical therapy had failed. The patients were randomly allocated to balloon dilation or to conventional frontal sinus drainage with a Draf I procedure. The main outcome measures were resolution of frontal sinus disease confirmed by computed tomographic scan, and permeability of the frontal recess seen on endoscopy, both at 12 months.
Results: Of the 40 patients enrolled, 32 concluded the trial. In both groups, we obtained a statistically significant reduction in the Lund-Mackay stage. Resolution of frontal sinus disease confirmed by computed tomographic scan seemed to be more common after balloon dilation, although this finding was not statistically significant. Permeability of the frontal recess was seen on endoscopy statistically more frequently after balloon treatment (73% versus 62.5%). Only 4 patients needed revision surgery. No major complications were observed.
Conclusions: Balloon dilation of the frontal recess is a relatively safe and effective tool in the management of chronic frontal rhinosinusitis after intensive medical treatment has failed.