Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial
| Autor: | Carine T M Hendriks, Maroeska M. Rovers, Gerjon Hannink, Niels van Heerbeek, Machteld M. H. T. van Egmond |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Nasal Surgical Procedures Perforation (oil well) 030204 cardiovascular system & hematology Turbinates law.invention Young Adult 03 medical and health sciences All institutes and research themes of the Radboud University Medical Center 0302 clinical medicine Randomized controlled trial Quality of life Adrenal Cortex Hormones law medicine Humans 030212 general & internal medicine Watchful Waiting Nose Aged Nasal Septum Netherlands Intention-to-treat analysis business.industry Nose Deformities Acquired General Medicine Middle Aged medicine.disease Intention to Treat Analysis Surgery Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] Deviated nasal septum Septoplasty Treatment Outcome medicine.anatomical_structure Urological cancers Radboud Institute for Health Sciences [Radboudumc 15] Quality of Life Female Nasal Obstruction Deviated septum business |
| Zdroj: | The Lancet (London), 394, 10195, pp. 314-321 The Lancet (London), 394, 314-321 |
| ISSN: | 0140-6736 |
| DOI: | 10.1016/s0140-6736(19)30354-x |
| Popis: | Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of septoplasty for nasal obstruction in adults with a deviated septum.We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have septoplasty done were randomly allocated (1:1) to receive either septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age (35 years or ≥35 years), and deviation severity (mild, moderate, or severe). The primary outcome was health-related quality of life, measured with the validated Glasgow Health Status Inventory at 12 months. Analyses were done on an intention-to-treat basis. The trial is registered with the Netherlands Trial Register, number NTR3868.Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5-12·1], favouring septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported.Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up.The Netherlands Organisation for Health Research and Development (ZonMw). |
| Databáze: | OpenAIRE |
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