Endoscopic sinus surgery (ESS) is a common operation in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical treatment alone is insufficient. No randomized controlled trials on the effectiveness of ESS have been published. Our aim was to assess the effectiveness of ESS plus medical treatment versus medical treatment alone in patients with CRSwNP.
We performed an open-label, multicenter, pragmatic, randomized, controlled trial in three tertiary care centers and 12 secondary care centers in 11 cities in the Netherlands (Almere, Amstelveen, Amsterdam, Blaricum, Den Haag, Deventer, Haarlem, Hoofddorp , Hoorn, Leiderdorp and Rotterdam). Adults (≥18 years of age) with CRSwNP and an indication of ESS were randomly allocated (1:1) using block randomization (blocks of six), stratified by study center, to receive either ESS plus medical treatment or medical treatment. ESS was performed according to local practice, although a previous ethmoidectomy was mandatory. Medical treatment was prescribed at the discretion of the patient’s otolaryngologist and could be, but was not limited to, nasal corticosteroids, nasal rinse, systemic corticosteroids, or systemic antibiotics. The primary outcome was disease-specific health-related quality of life (HRQoL) at 12 months follow-up, measured with the validated Sinonasal Outcome Test 22 (SNOT-22; where each item is scored from 0 to 5 , where 0 indicated no problems and 5 indicates problems as bad as possible, with a total score of 0 to 110 points), and the minimal clinically important difference of the SNOT-22 is 9.0 points. Primary and safety analyzes were performed by intention to treat (ITT). The ITT population included all patients who were randomly assigned to treatment based on their randomization group and without any protocol violations. This study is registered with the Netherlands Trials Register, NTR4978, and is ongoing.
Between February 15, 2015, and August 27, 2019, 371 patients were screened for eligibility, of whom 238 were eligible, willing to participate, and randomly assigned to ESS plus medical treatment (n=121) or medical treatment ( n = 117) and 234 were included in the initial ITT population (n = 118 ESS plus medical treatment; n = 116 medical treatment). 142 (61%) of the 234 patients at baseline were male and 92 (39%) were female, and the mean age was 50·4 years (SD 12·7). 206 participants were analyzed at 12 months for the primary endpoint (n = 103 in the ESS plus medical therapy group; n = 103 in the medical therapy group). At 12 months of follow-up, the mean SNOT-22 score in the ESS plus medical treatment group was 27 9 (SD 20 2; n=103) and in the medical treatment group 31 1 (20 4; n =103), with an adjusted mean difference of -4·9 (95% CI -9·4 to -0·4), favoring ESS over medical treatment. Adverse events were similar between the groups. The most common adverse events were minor epistaxis or gastrointestinal problems. No treatment-related deaths occurred, but one patient died of congestive heart failure.
ESS plus medical therapy is more effective than medical therapy alone in patients with CRSwNP, although the minimal clinically important difference was not reached. Long-term follow-up data is needed to determine if the effect persists. The current results form a basis for the further development of evidence-based guidelines.
The Netherlands Organization for Health Research and Development (ZonMw).