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- Title
REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.
- Authors
Chandra, Rakesh K.; Kern, Robert C.; Cutler, Jeffrey L.; Welch, Kevin C.; Russell, Paul T.
- Abstract
<bold>Objectives/hypothesis: </bold>To provide the final results from the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long-term follow-up) full-study cohorts and perform meta-analyses of standalone balloon sinus dilation studies to explore long-term outcomes in a large patient sample.<bold>Study Design: </bold>Randomized controlled trial and meta-analysis.<bold>Methods: </bold>Final outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with functional endoscopic sinus surgery (FESS) or in-office balloon dilation, were evaluated. One hundred thirty patients had 12-month data, 66 had 18-month data, and 25 had 24-month data. In addition, a meta-analysis evaluated outcomes from six studies including 358 standalone balloon dilation patients with up to 24 months follow-up.<bold>Results: </bold>Outcomes out to 2 years from the REMODEL full-study cohort are consistent with 6-month and 12-month outcomes. In the meta-analysis of standalone balloon dilation studies, technical success is 97.5%, and mean 20-item Sino-Nasal Outcomes Test scores are significantly and clinically improved at all time points (P < .0001). There are significant reductions (P < .0001) in work/school days missed, homebound days, physician/nurse visits, acute infections, and antibiotic prescriptions. Mean recovery time is 1.4 days. Comparison of 12-month symptom improvements and revision rates between the REMODEL FESS arm (n = 59), REMODEL balloon dilation arm (n = 71), and pooled single-arm standalone balloon dilation studies (n = 243) demonstrated no statistical difference.<bold>Conclusions: </bold>All outcomes are comparable between FESS and balloon dilation at all time points from 6 months to 24 months. Balloon dilation produces faster recovery, less postoperative pain, and fewer debridements than FESS. There is significant, durable benefit in a large series of 358 patients undergoing standalone balloon dilation.
- Subjects
SINUSITIS treatment; MEDICAL balloons; PARANASAL sinus surgery; POSTOPERATIVE pain; HEALTH outcome assessment; META-analysis; RHINITIS treatment; CATHETERIZATION; COMPARATIVE studies; ENDOSCOPY; LONGITUDINAL method; MAXILLARY sinus; RESEARCH methodology; MEDICAL cooperation; RESEARCH; TIME; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness
- Publication
Laryngoscope, 2016, Vol 126, Issue 1, p44
- ISSN
0023-852X
- Publication type
journal article
- DOI
10.1002/lary.25507