Abstract
BackgroundSeptoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform septoplasty is nasal obstruction. However, the effectiveness of septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures.Methods/DesignThe study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis.DiscussionWith the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty.Trial registrationNederlands Trial Register/Dutch Trial Registry (www.trialregister.nl), trial identifying number: NTR3868. Registered on 21 February 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1031-4) contains supplementary material, which is available to authorized users.
Highlights
Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults
With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty
The study is conducted in accordance with principles of Good Clinical Practice. For this reason we have developed a monitoring plan for data collection, aiming for: Cost-effectiveness analysis As evidence regarding the cost-effectiveness of septoplasty is lacking, the main objective of the economic evaluation is to assess the balance between costs and effects of septoplasty as compared to watchful waiting for nasal obstruction in patients with a deviated nasal septum
Summary
This ongoing pragmatic randomized controlled trial is the first study to assess the effectiveness of septoplasty compared to non-surgical management for nasal obstruction due to a deviated nasal septum in adults. We chose health-related quality of life as primary outcome measure to focus on the patient rather than the disease, as septoplasty aims at improving nasal symptoms and not merely straightening the nasal septum Another strength of our study is the relatively long duration of follow-up, i.e., 2 years for each participant. In order to evaluate representativeness of our trial sample, we will conduct a future study in which baseline measurements (including demographic and disease-specific characteristics: e.g., type and severity of the nasal septal deviation) will be performed in all patients selected for septoplasty in a Dutch hospital not participating in the current trial.
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