Clinical benefit and cost effectiveness of endoscopic sinus surgery (ESS) in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP)

Given its prevalence (11% in Europe, 14,6% in the Netherlands) and the significant negative effect on quality of life, the diagnosis and treatment of chronic rhinosinusitis (CRS) is associated with a significant medical resource use and societal economic burden. CRS has been shown to have a negative impact on most aspects of Health related Quality of Life
and has a greater impact on HRQoL than chronic heart failure, angina, diabetes or back pain. CRS is the most common reason for surgery (ESS) in adult patients in the otorhinolaryngological practice with around 18,000 ESS performed in The Netherlands yearly (2010 data stichting hospital data (DHD)). CRS can be divided into the more serious disease CRS with nasal polyps (CRSwNP) (prevalence 1-­4%) and CRS without nasal polyps (CRSsNP). Around 70% of the ESS is done in patients with CRSwNP. Surgery requires anaesthesia and convalescence and has a small but relevant risk of serious (intracranial) complications. At present it is unknown whether ESS added to drug treatment offers significant benefits over drug treatment alone. The objective of this open multi-centre randomized trial is to
investigate whether these two regular used strategies in adults with CRSwNP differ in improvement in health related quality of life (SNOT-22, EQ-5D-5L) at 12 months follow-up (primary outcome). Furthermore both strategies will be compared with respect to cost-effectiveness. Based on the primary outcome measurement, a sample size of 238 patients will have 90% power to detect a difference in means of 8.9, standard devitation 20.0 using a 0.05 two-sided significance level. Eligible patients will be randomized to a. ESS within 6 weeks in addition to drug treatment, or b. drug treatment alone. We will need 2 months start-up, 18 months of inclusion and 24 months follow-up.

Current practice variance in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) is not efficient. Endoscopic sinus surgery (ESS) is the most common ENT operation in adults in the Netherlands. The
objective of the present study is to investigate the clinical effectiveness and cost-­effectiveness of two regular
used strategies (“ESS in addition to drug treatment (usual care)” versus “drug treatment alone”) in adults with
CRSwNP with regard to improvement in health related quality of life (HRQoL: SNOT-­22, EQ-­5D-­5L) at 12 months follow-­up.

N/A

Eligible patients will be randomly assigned in a 1:1 ratio to one of both interventions:

1. a surgical strategy consisting of ESS in addition to drug treatment. Those assigned to the surgical strategy will be offered endoscopic sinus surgery within 6 weeks of randomization. In this study we mean by endoscopic sinus surgery the surgery as done regularly by otorhinolaryngologists in the Netherlands. We do not standardize surgery.

2. a medical strategy consisting of drug treatment alone.Those assigned to the drug treatment strategy will be seen by the otorhinolaryngologist within 6 weeks of randomization to evaluate the need for additional medical treatment. Drug treatment can be any treatment that is normally given in routine medical practice to treat CRSwNP. We do not standardize drug treatment because we want to stay closest to standard of care.
The randomization will be website-­based, using block randomization and stratified by study centre.