Evidence map›Paper›PMID 26228589›Full record

Trial reportThe Laryngoscope2016

REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.

Rakesh K Chandra, Robert C Kern, Jeffrey L Cutler, Kevin C Welch, Paul T Russell

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Laryngoscope, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01525849 (Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01525849 nacompletednot on this map

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

TypeinterventionalSponsorEntellus Medical, Inc.Ran2011 to 2014Enrolled151ConditionsChronic SinusitisArmsBalloon Sinus Dilation, Functional Endoscopic Sinus Surgery
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2018
    Trial
  3. Review
  4. Article
  5. Short- and long-term costs of sinus balloon sinuplasty and middle meatal antrostomy.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Awake Rhinology Surgery in Response to the COVID-19 Pandemic in Europe.ORL; journal for oto-rhino-laryngology and its related specialties · 2022
    Review
  11. Current and Future Treatments of Rhinitis and Sinusitis.The journal of allergy and clinical immunology. In practice · 2020
    Review
  12. Review
  13. Article
  14. Evidence and evidence gaps in therapies of nasal obstruction and rhinosinusitis.GMS current topics in otorhinolaryngology, head and neck surgery · 2016
    Review
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Rakesh K ChandraDepartment of Otolaryngology, Vanderbilt University School of Medicine, Nashville, Tennessee.
Robert C KernDepartment of Otolaryngology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Jeffrey L CutlerAssociates of Otolaryngology, Denver, Colorado, U.S.A.
Kevin C WelchDepartment of Otolaryngology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Paul T RussellDepartment of Otolaryngology, Vanderbilt University School of Medicine, Nashville, Tennessee.
Northwestern University · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectives/hypothesisTo 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. STUDY

designRandomized controlled trial and meta-analysis.

methodsFinal 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.

resultsOutcomes 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.

conclusionsAll 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.

Indexed as

Maxillary SinusAdultCatheterizationEndoscopyFemaleFollow-Up StudiesHumansMaleMeta-Analysis as TopicRhinitisSinusitisTime FactorsTreatment OutcomeBalloon sinus dilationchronic rhinosinusitisendoscopic sinus surgerylong-term outcomesmeta-analysisrandomized controlled trial

Identifiers

PMID26228589
PMCPMC5132108
OpenAlexW1938428088

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.