BACKGROUND: The objectives of this study were as follows: (1) to evaluate frontal sinus ostial patency following balloon dilation with the Ventera Sinus Dilation System, compared with frontal sinusotomy (Draf 2a); and (2) to compare mean blood loss and mean surgical time for frontal sinusotomy using balloon dilation compared with traditional surgical methods. METHODS: A single blinded, randomized, controlled, prospective study was performed at St. Paul's Sinus Center, Vancouver, a tertiary referral rhinology center. Thirty patients undergoingfunctional endoscopic sinus surgery (FESS) for chronic rhinosinusitis (CRS) were randomized to a hybrid approach with exposure of the frontal recess using standard instrumentation and then balloon dilation of 1 frontal sinus drainage pathway and traditional frontal sinusotomy for the opposite side. Blood loss and surgical time for opening the frontal sinus drainage pathway was recorded for each side. Patients acted as their own controls. Ostial patency and size were assessed 5 weeks and 3 months postoperatively using endoscopy. Ostial patency was also recorded at 1 year following surgery. RESULTS: All frontal sinus ostia in both groups (n = 30) were successfully opened and were patent with both techniques 3 months postoperatively. All frontal sinus ostia assessed at 1 year (73%) remained patent and none required revision frontal surgery. Balloon dilation showed a mean surgical time of 655 seconds compared to 898 seconds for traditional FESS (p = 0.03). Mean blood loss was less with balloon dilation (58 mL vs 91 mL; p = 0.008). CONCLUSION: A hybrid balloon technique successfully dilates the frontal sinus drainage pathway with reduced blood loss. Also, short-term patency appears to be comparable to traditional frontal sinusotomy.
RCT Entities:
BACKGROUND: The objectives of this study were as follows: (1) to evaluate frontal sinus ostial patency following balloon dilation with the Ventera Sinus Dilation System, compared with frontal sinusotomy (Draf 2a); and (2) to compare mean blood loss and mean surgical time for frontal sinusotomy using balloon dilation compared with traditional surgical methods. METHODS: A single blinded, randomized, controlled, prospective study was performed at St. Paul's Sinus Center, Vancouver, a tertiary referral rhinology center. Thirty patients undergoing functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis (CRS) were randomized to a hybrid approach with exposure of the frontal recess using standard instrumentation and then balloon dilation of 1 frontal sinus drainage pathway and traditional frontal sinusotomy for the opposite side. Blood loss and surgical time for opening the frontal sinus drainage pathway was recorded for each side. Patients acted as their own controls. Ostial patency and size were assessed 5 weeks and 3 months postoperatively using endoscopy. Ostial patency was also recorded at 1 year following surgery. RESULTS: All frontal sinus ostia in both groups (n = 30) were successfully opened and were patent with both techniques 3 months postoperatively. All frontal sinus ostia assessed at 1 year (73%) remained patent and none required revision frontal surgery. Balloon dilation showed a mean surgical time of 655 seconds compared to 898 seconds for traditional FESS (p = 0.03). Mean blood loss was less with balloon dilation (58 mL vs 91 mL; p = 0.008). CONCLUSION: A hybrid balloon technique successfully dilates the frontal sinus drainage pathway with reduced blood loss. Also, short-term patency appears to be comparable to traditional frontal sinusotomy.