Abstract
Objective: 1) To evaluate frontal sinus ostia patency after balloon dilation with the Ventera Sinus Diltation System (which has not been tested before) compared with traditional frontal sinusotomy. 2) To compare the mean blood loss and the mean surgical time for frontal sinusotomy during balloon dilatation compared with traditional methods.
Method: A single-blinded, randomized, controlled, prospective study of 30 patients will be conducted. Patients undergoing FESS for chronic rhinosinusitis are randomized to balloon dilation of 1 frontal sinus and traditional frontal sinusotomy on the opposite sinus. Patients act as their own controls. Ostial patency and size will be assessed 5 weeks, 3 months, and 6 months postoperatively using endoscopy and curved suctions.
Results: Our initial results in 19 patients are promising. All frontal sinus ostia in both groups were successfully opened and 100% were patent with both techniques at 5 weeks and 3 months postoperatively. Balloon dilatation shows a mean surgical time of 10 minutes compared with 18 minutes in traditional FESS. Mean blood loss is less with balloon dilatation (54 mL vs 86 mL).
Conclusion: The initial findings suggest the Ventera Sinus Dilation System is easy to use and successfully dilates the frontal sinus ostia quicker and with less blood loss. Also, short-term patency appears to be comparable to traditional frontal sinusotomy.
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