OBJECTIVES/HYPOTHESIS: The aim of this study was to evaluate the effects of a nonabsorbable packing (NAP) in the middle meatus (MM) for 5 days after sinus surgery. STUDY DESIGN: A randomized, partly blinded, controlled clinical trial. METHODS:Sixty-one patients (M/F = 30/31, mean age 42, range 18-72) with chronic or acute recurrent rhinosinusitis were included. Fifty-nine underwent surgery. Thirty-one had NAP in the MM for 5 days, and 28 served as controls with daily saline irrigations postoperatively. Primary outcome variables were nasal congestion, nasal pain, and headache the first 2 weeks rated on visual analogue scales (VAS; 0-100) and the amount of postoperative bleeding recorded on an ordinal scale (1-4). Secondary outcome variable was the extent of adhesions in MM 10 to 14 weeks after surgery judged by blinded evaluation of endoscopic video recordings. RESULTS: Fifty-eight patients completed a diary. No significant differences in primary outcome variables between the groups were found. Nasal congestion decreased most the first 5 to 7 days postoperatively. Removal of the NAP caused little pain (mean 23 on VAS). Temporary bleeding occurred in three patients. Bilateral adhesions were observed in 10 control patients but in none with NAP. Unilateral adhesions were found in nine control patients and in seven with NAP (exact P < .001). CONCLUSIONS:NAP in the MM for 5 days significantly reduced the extent of adhesions in MM compared with saline irrigation alone. NAP did not cause additional discomfort.
RCT Entities:
OBJECTIVES/HYPOTHESIS: The aim of this study was to evaluate the effects of a nonabsorbable packing (NAP) in the middle meatus (MM) for 5 days after sinus surgery. STUDY DESIGN: A randomized, partly blinded, controlled clinical trial. METHODS: Sixty-one patients (M/F = 30/31, mean age 42, range 18-72) with chronic or acute recurrent rhinosinusitis were included. Fifty-nine underwent surgery. Thirty-one had NAP in the MM for 5 days, and 28 served as controls with daily saline irrigations postoperatively. Primary outcome variables were nasal congestion, nasal pain, and headache the first 2 weeks rated on visual analogue scales (VAS; 0-100) and the amount of postoperative bleeding recorded on an ordinal scale (1-4). Secondary outcome variable was the extent of adhesions in MM 10 to 14 weeks after surgery judged by blinded evaluation of endoscopic video recordings. RESULTS: Fifty-eight patients completed a diary. No significant differences in primary outcome variables between the groups were found. Nasal congestion decreased most the first 5 to 7 days postoperatively. Removal of the NAP caused little pain (mean 23 on VAS). Temporary bleeding occurred in three patients. Bilateral adhesions were observed in 10 control patients but in none with NAP. Unilateral adhesions were found in nine control patients and in seven with NAP (exact P < .001). CONCLUSIONS:NAP in the MM for 5 days significantly reduced the extent of adhesions in MM compared with saline irrigation alone. NAP did not cause additional discomfort.
Authors: Lin Shi; Ya Feng; Wanming Cui; Kaisheng Yan; Mei Lv; Zhijun Hong; Mingyu Wang; Lijie Zhai; Haolin Wang Journal: Int J Clin Exp Med Date: 2015-01-15