Erin D Wright1, Sumit Agrawal. 1. Department of Surgery, Division of Otolaryngology, University of Alberta, Edmonton, Alberta, Canada. erinwright@capitalhealth.ca
Abstract
OBJECTIVES/HYPOTHESIS: The objective of this randomized, double-blind, placebo-controlled study was to assess the effect of perioperative systemic steroids on subjective and objective surgical outcomes for patients undergoingendoscopic sinus surgery (ESS) for chronic rhinosinusitis with polyposis (CRSwP). The secondary objective was to begin validation of the newly developed Perioperative Sinus Endoscopy (POSE) scoring system. METHODS:Patients who had failed maximal medical therapy and were scheduled to undergo ESS were eligible for the study. Participants were randomized to receive either 30 mg of prednisone or placebo for 5 days preoperatively and 9 days postoperatively. Operative and baseline clinical data were collected using the Lund-McKay staging system including its Sinus Symptom Questionnaire as well as additional data regarding mucosal health, the technical difficulty of surgery, and endoscopic data using the Lund-Kennedy Endoscopic Score (LKES) and POSE scale. Data were also collected at 2 weeks, 1 month, 3 months, and 6 months postoperatively. A sample size of 24 was calculated to detect a clinically relevant difference between groups of 40%. Routine statistical comparisons were performed as were repeated measures analysis of variance with Bonferroni adjustment because of the multiple comparisons performed. To address the secondary objective, data were also collected at all postoperative time points using the POSE instrument, which was designed with the intention of enhancing face validity and responsiveness to change. Comparisons were performed between the POSE and LKES, including assessment of sensitivity to change, correlation between the two scales, and correlation with symptom scores. RESULTS:Twenty-six patients participated in the study. Operative data demonstrated a significantly higher percentage of severely inflamed sinonasal mucosa in patients not pretreated with systemic steroids, which was associated with technically more difficult surgery in the estimation of the operating surgeon. In terms of postoperative symptoms, there was no difference between treatment groups, with both placebo and prednisone significantly improved over baseline up to 4 weeks postoperatively. Endoscopic assessment of patients postoperatively demonstrated a treatment effect (P < .05), with clinically healthier cavities seen in patients treated with prednisone up to 6 months postoperatively as compared with baseline (P < .001), although the strongest effect was seen at the 2-week time point. In comparing the two endoscopic scales, the POSE and LKES correlated highly (R > 0.70; P < .001) both in terms of absolute score and change in score. There is some evidence that the POSE score may be more sensitive to change than the LKES, and the POSE scores did correlate more strongly with symptom scores than the LKES, although both endoscopic scores correlated only weakly with symptom scores. CONCLUSIONS: The data presented in this study support the practice of administering preoperative systemic steroids to patients undergoing ESS for CRSwP. Furthermore, in the practice of surgeons who provide intensive postoperative care post-ESS, including debridement and medical therapy based on the endoscopic findings, there is evidence to support administering systemic steroids in the postoperative period. The POSE scoring system compares favorably with the LKES and may confer advantages in terms of face/content validity and responsiveness to change and is worthy of further validation.
RCT Entities:
OBJECTIVES/HYPOTHESIS: The objective of this randomized, double-blind, placebo-controlled study was to assess the effect of perioperative systemic steroids on subjective and objective surgical outcomes for patients undergoing endoscopic sinus surgery (ESS) for chronic rhinosinusitis with polyposis (CRSwP). The secondary objective was to begin validation of the newly developed Perioperative Sinus Endoscopy (POSE) scoring system. METHODS:Patients who had failed maximal medical therapy and were scheduled to undergo ESS were eligible for the study. Participants were randomized to receive either 30 mg of prednisone or placebo for 5 days preoperatively and 9 days postoperatively. Operative and baseline clinical data were collected using the Lund-McKay staging system including its Sinus Symptom Questionnaire as well as additional data regarding mucosal health, the technical difficulty of surgery, and endoscopic data using the Lund-Kennedy Endoscopic Score (LKES) and POSE scale. Data were also collected at 2 weeks, 1 month, 3 months, and 6 months postoperatively. A sample size of 24 was calculated to detect a clinically relevant difference between groups of 40%. Routine statistical comparisons were performed as were repeated measures analysis of variance with Bonferroni adjustment because of the multiple comparisons performed. To address the secondary objective, data were also collected at all postoperative time points using the POSE instrument, which was designed with the intention of enhancing face validity and responsiveness to change. Comparisons were performed between the POSE and LKES, including assessment of sensitivity to change, correlation between the two scales, and correlation with symptom scores. RESULTS: Twenty-six patients participated in the study. Operative data demonstrated a significantly higher percentage of severely inflamed sinonasal mucosa in patients not pretreated with systemic steroids, which was associated with technically more difficult surgery in the estimation of the operating surgeon. In terms of postoperative symptoms, there was no difference between treatment groups, with both placebo and prednisone significantly improved over baseline up to 4 weeks postoperatively. Endoscopic assessment of patients postoperatively demonstrated a treatment effect (P < .05), with clinically healthier cavities seen in patients treated with prednisone up to 6 months postoperatively as compared with baseline (P < .001), although the strongest effect was seen at the 2-week time point. In comparing the two endoscopic scales, the POSE and LKES correlated highly (R > 0.70; P < .001) both in terms of absolute score and change in score. There is some evidence that the POSE score may be more sensitive to change than the LKES, and the POSE scores did correlate more strongly with symptom scores than the LKES, although both endoscopic scores correlated only weakly with symptom scores. CONCLUSIONS: The data presented in this study support the practice of administering preoperative systemic steroids to patients undergoing ESS for CRSwP. Furthermore, in the practice of surgeons who provide intensive postoperative care post-ESS, including debridement and medical therapy based on the endoscopic findings, there is evidence to support administering systemic steroids in the postoperative period. The POSE scoring system compares favorably with the LKES and may confer advantages in terms of face/content validity and responsiveness to change and is worthy of further validation.