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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effectiveness of septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: study protocol for a randomized controlled trial

Authors: M. M. H. T. van Egmond, M. M. Rovers, C. T. M. Hendriks, N. van Heerbeek

Published in: Trials | Issue 1/2015

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Abstract

Background

Septoplasty, 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/Design

The 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.

Discussion

With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty.

Trial registration

Nederlands Trial Register/Dutch Trial Registry (www.​trialregister.​nl), trial identifying number: NTR3868. Registered on 21 February 2013.
Appendix
Available only for authorised users
Footnotes
1
For reasons of feasibility, in selected cases health-related quality of life questionnaires may be administered digitally to participants prior to the baseline visit. In case a subject decides to withdraw informed consent during the baseline visit, questionnaire derived data will be destroyed.
 
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Metadata
Title
Effectiveness of septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: study protocol for a randomized controlled trial
Authors
M. M. H. T. van Egmond
M. M. Rovers
C. T. M. Hendriks
N. van Heerbeek
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1031-4

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