Endoscopic sinus surgery in adult patients with chronic rhinosinusitis with nasal polyps (PolypESS): study protocol for a randomised controlled trial.
Trials
; 18(1): 39, 2017 01 23.
Article
en En
| MEDLINE
| ID: mdl-28114954
ABSTRACT
BACKGROUND:
Chronic rhinosinusitis with nasal polyps is a chronic disease frequently seen in otorhinolaryngological practice. Along with its chronic disease burden it creates high societal costs. Therapy consists of long-term use of medication and, if insufficient, endoscopic sinus surgery. No consensus exists on the right timing and extent of disease that warrants surgery. Furthermore, there is lack of clinical knowledge about the benefit of surgery over medication only. The current trial evaluates the clinical effectiveness and cost-effectiveness of endoscopic sinus surgery in addition to drug treatment versus medication exclusively in the adult patient group with nasal polyps.METHODS:
A prospective, multicentre, superiority, randomised controlled (PolypESS) trial in 238 patients aged 18 years or older selected for primary or revision endoscopic sinus surgery by the otorhinolaryngologist was designed. Patients will be randomised to either endoscopic sinus surgery in addition to medication or medical therapy only. Relevant data will be collected prior to randomisation, at baseline and 3, 6, 12, 18 and 24 months after start of treatment. Complete follow-up will be 24 months. Primary outcome is disease-specific Health-related Quality of Life quantified by the SNOT-22 after 12-month follow-up. Secondary outcomes are generic Health-related Quality of Life, cost-effectiveness, objective signs of disease and adverse effects of treatment. Subgroup analyses will be performed to verify whether treatment effects differ among patient phenotypes.DISCUSSION:
The PolypESS trial will investigate tailored care in adult patients with chronic rhinosinusitis with nasal polyps and will result in improved clinical pathways to help to determine in which circumstances to perform surgery. TRIAL REGISTRATION Dutch Trial Register, NTR4978 . Registered on 27 November 2014.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Senos Paranasales
/
Sinusitis
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Procedimientos Quirúrgicos Otorrinolaringológicos
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Rinitis
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Pólipos Nasales
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Endoscopía
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
/
Observational_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2017
Tipo del documento:
Article
País de afiliación:
Países Bajos