Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicentre, randomised, controlled trial.

BACKGROUND: Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient. No randomised controlled trials on the efficacy of ESS have been published. We aimed to assess the efficacy of ESS plus medical therapy versus medical therapy alone in patients with CRSwNP. METHODS: We performed an open-label, multicentre, pragmatic, randomised, controlled trial in three tertiary care centres and 12 secondary care centres in 11 cities in the Netherlands (Almere, Amstelveen, Amsterdam, Blaricum, Den Haag, Deventer, Haarlem, Hoofddorp, Hoorn, Leiderdorp, and Rotterdam). Adults (aged ≥18 years) with CRSwNP and an indication for ESS were randomly assigned (1:1) using block randomisation (block sizes of six), stratified by study centre, to receive either ESS plus medical therapy or medical therapy. ESS was performed according to local practice, although anterior ethmoidectomy was mandatory. Medical therapy was prescribed at the patient's otorhinolaryngologist's discretion, and could be, but was not limited to, nasal corticosteroids, nasal rinsing, systemic corticosteroids, or systemic antibiotics. The primary outcome was disease-specific health-related quality of life (HRQoL) at 12 months of 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 can be, with a total score of 0-110 points), and the minimal clinically important difference of the SNOT-22 is 9·0 points. Primary and safety analyses were performed on an intention-to-treat (ITT) basis. The ITT population comprised all patients who were randomly assigned to treatment according to their randomisation group and without any protocol violation. This study is registered with the Netherlands Trial Register, NTR4978, and is ongoing. FINDINGS: Between Feb 15, 2015, and Aug 27, 2019, 371 patients were screened for eligibility, of whom 238 were eligible, willing to participate, and randomly assigned to ESS plus medical therapy (n=121) or medical therapy (n=117) and 234 were included in the baseline ITT population (n=118 ESS plus medical therapy; n=116 medical therapy). 142 (61%) of 234 patients at baseline were men and 92 (39%) were women, and the mean age was 50·4 years (SD 12·7). 206 participants were analysed at 12 months for the primary outcome (n=103 in the ESS plus medical therapy group; n=103 in the medical therapy group). At 12 months follow-up, the mean SNOT-22 score in the ESS plus medical therapy group was 27·9 (SD 20·2; n=103) and in the medical therapy group was 31·1 (20·4; n=103), with an adjusted mean difference of -4·9 (95% CI -9·4 to -0·4), favouring ESS plus medical therapy. 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 due to congestive heart failure. INTERPRETATION: ESS plus medical therapy is more efficacious than medical therapy alone in patients with CRSwNP, although the minimal clinically important difference was not met. Long-term follow-up data are needed to determine whether the effect persists. The current results are a basis for further development of evidence-based guidelines. FUNDING: The Netherlands Organisation for Health Research and Development (ZonMw).

Eye for an eye: near-fatal outcome of fungal infection in a young, diabetic girl.

In this report, we describe the case of a young, diabetic girl with ketoacidosis who suffered sudden loss of vision of the right eye. The loss of vision was caused by an invasive rhino-orbital-cerebral fungal infection (mucormycosis) with extensive periorbital thrombosis. Despite maximal antifungal and surgical treatment (including exenteration of the right orbit), the clinical situation deteriorated. It was only after overcoming the difficulties of managing her hyperglycaemia that the patient's condition stabilised and her life was saved. Another factor contributing to this girls' survival was the swift diagnosis of mucormycosis, which was made soon after the onset of symptoms. Because of this, treatment could be started almost immediately.

Safety and efficacy of a bioabsorbable fluticasone propionate-eluting sinus dressing in postoperative management of endoscopic sinus surgery: a randomized clinical trial.

BACKGROUND: Postoperative wound healing after endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS) is an important factor in procedural success. Local steroids and separation of opposing mucosa are commonly implemented to optimize healing. A bioabsorbable, fluticasone propionate (FP)-eluting implant, SinuBand FP, was assessed for its safety and efficacy when used in patients with CRS and nasal polyps, who were indicated for ESS including bilateral anterior and posterior ethmoidectomy. METHODS: A first-in-human, randomized, partially double-blind, single-tertiary-referral-center, controlled trial enrolling 30 patients receiving 2 of 3 treatments (1 per sinus, intrapatient control): SinuBand FP, SinuBand (without FP), or standard nasal pack (Merocel®). Primary outcome measures were local safety, ocular safety (intraocular pressure [IOP], lens opacity), and 24-hour urine cortisol. Secondary measures (evaluated by independent review of postoperative video endoscopies) were ethmoid inflammation, polyp score, adhesion formation, and Lund-Kennedy score. Patient-reported outcomes of postoperative pain, nasal congestion, and nasal discharge were collected. RESULTS: Of 30 enrolled patients (used for safety analysis), 27 patients completed the trial. SinuBand FP showed local safety, ocular safety, and no significant change in 24-hour urine cortisol. SinuBand FP showed a trend to do better concerning inflammation. Concerning polyp score SinuBand FP did significantly better compared to Merocel (p = 0.03). No significance compared to SinuBand without corticosteroids (p = 0.97). Adhesions were comparable across treatments. Patient reported pain was nominally lower in the SinuBand group. CONCLUSION: SinuBand FP was well tolerated and showed evidence of efficacy. A larger study is needed to further evaluate and confirm the benefits of SinuBand FP.

Challenges in the Management of Inverted Papilloma: A Review of 72 Revision Cases.

OBJECTIVES/HYPOTHESIS: We report on the treatment outcome of endoscopically managed sinonasal inverted papilloma, focusing on revision cases. Our aim was to identify the properties of revision cases that affect treatment outcome by comparing them to primary cases in a single center. We propose using 5-fluorouracil (5-FU) in the postoperative management of inverted papilloma. STUDY DESIGN: A retrospective single-center case series. This study met the criteria for approval by the local medical ethics committee. METHODS: We performed a retrospective chart review identifying patients operated on between January 2003 and September 2013. Data were collected about patient demographics, symptoms, tumor attachment site, imaging, intraoperative and pathological findings, surgical approaches, postoperative treatment, follow-up, and recurrence. RESULTS: One hundred and twenty-one (72 revision and 49 primary) cases were retrieved with a minimum follow-up of 1 year. Revision cases have significantly higher Krouse staging (P = 0.003), different distribution of tumor attachment sites, and higher recurrence rates. The recurrence rate was 4.1% for primary cases (mean follow-up 35.5 months) and 18.1% for revision cases (mean follow-up 45 months). Eight of the recurrent cases recurred within the first year. 5-fluorouracil was applied postoperatively in 18 (5 primary and 13 revision) cases, which included one (5.6%) recurrence and one minor complication (transient periorbital swelling). CONCLUSION: The most important factors in preventing the recurrence of inverted papilloma are the determination of the location of the attachment and the completeness of resection in the primary endoscopic surgery. Revision cases have a higher recurrence rate, and the attachment sites are surgically more challenging. The use of 5-FU might have a place in the postoperative treatment of surgically challenging inverted papilloma. LEVEL OF EVIDENCE: 4.

Chronic rhinosinusitis: an update on current pharmacotherapy.

INTRODUCTION: Chronic rhinosinusitis (CRS) is an inflammatory disease of the nasal and paranasal mucosa with great impact on quality of life and a large financial burden on society. This article provides an overview of its current and future pharmacotherapy, the mainstay of CRS treatment. AREAS COVERED: This article reviews the etiology, antibiotic and corticosteroid treatment, nasal irrigation therapy, bacterial lysates, anti-immunoglobulin E and anti-interleukin-5 therapy of CRS. This review highlights articles of interest on these topics in the PubMed database. Studies not in English language were excluded. EXPERT OPINION: CRS is a spectrum of disease characterized by mucosal inflammation. Defining its various subtypes will change its medical treatment from general anti-inflammatory medicine towards tailor-made pharmacotherapy. The optimal timing of endoscopic sinus surgery in this treatment process remains to be defined.