Local budesonide therapy in the management of persistent hyposmia in suspected non-severe COVID-19 patients: Results of a randomized controlled trial.

OBJECTIVES: Consequences of COVID-19 on olfactory functions remained unclear during the pandemic. We assessed the efficacy of local budesonide in addition to olfactory rehabilitation when managing non-severe COVID-19 patients with persistent hyposmia. METHODS: A multicentric, randomized, superiority trial was conducted (ClinicalTrials.gov NCT04361474). The experimental group (EG) received budesonide and physiological saline nasal irrigations administered via three syringes of 20 ml in each nasal cavity in the morning and evening for 30 days. The control group (CG) received a similar protocol without budesonide. Patients were included if they were >18 years old, with a SARS-CoV-2 infection and presenting an isolated hyposmia persisting 30 days after symptom onset. The primary endpoint was the percentage of patients with improvement of more than two points on the ODORATEST score after 30 days of treatment. RESULTS: In total, 123 patients were included and randomized (EG: 62 vs CG: 61). Two patients from the EG met the primary endpoint with no statistical difference between the two groups (P = 0.5). CONCLUSION: To our knowledge, this is the first study evaluating local budesonide for COVID-19 related hyposmia treatment even though previous trials were performed with other local corticosteroids. Local budesonide efficacy was not demonstrated for persistent hyposmia related to COVID-19.

Transoral robotic surgery for sellar tumors: first clinical study.

OBJECTIVE The aim of this study was to confirm the feasibility of an innovative transoral robotic surgery (TORS), using the da Vinci Surgical System, for patients with sellar tumors. This technique was designed to offer a new minimally invasive approach, without soft-palate splitting, that avoids the rhinological side effects of classic endonasal approaches. METHODS The authors performed a prospective study of TORS in patients with symptomatic sellar tumors. Specific anatomical features were required for inclusion in the study and were determined on the basis of preoperative open-mouth CT scans of the brain. The main outcome measure was sellar accessibility using the robot. Resection quality, mean operative time, postoperative changes in patients' vision, side effects, and complications were additionally reported. RESULTS Between February and May 2016, 4 patients (all female, mean age 49.5 years) underwent TORS for resection of sellar tumors as participants in this study. All patients presented with symptomatic visual deficits confirmed as bitemporal hemianopsia. All tumors had a suprasellar portion and a cystic part. In all 4 cases, the operation was performed via TORS, without the need for a second surgery. Sella turcica accessibility was satisfactory in all cases. In 3 cases, tumor resection was complete. The mean operative time was 2 hours 43 minutes. Three patients had a significant visual improvement at Day 1. No rhinological side effects or complications in patients occurred. No pathological examination was performed regarding the fluid component of the tumors. There was 1 postoperative delayed CSF leak and 1 case of transient diabetes insipidus. Side effects specific to TORS included minor sore throat, transient hypernasal speech, and 1 case of delayed otitis media. The mean length of hospital stay and mean follow up were 8.25 days and 82 days, respectively. CONCLUSIONS To our knowledge, this is the first report of the surgical treatment of sellar tumors by means of a minimally invasive TORS. This approach using the da Vinci Surgical System seems feasible and constitutes an innovative neurosurgical technique that may avoid the adverse side effects and technical disadvantages of the classic transsphenoidal route. Moreover, TORS allows an inferosuperior approach to the sella turcica, which is a key point, as the tumor is approached in the direction of its growth.

Conservative management of 386 cases of unilateral vestibular schwannoma: tumor growth and consequences for treatment.

OBJECT: The object of this study was to evaluate the natural history, pattern, and occurrence of tumor growth and its consequences for treatment of small-sized vestibular schwannomas (VSs). METHODS: From 1990 to 2005, 386 patients underwent conservative management for VS because of the following: age > 60 years, poor health/medical risks, risk of deterioration of good hearing, small tumor size, minimal or no incapacitating symptoms, and/or patient preference. Tumor size was measured by MR imaging according to the guidelines of the Committee on Hearing and Equilibrium. The first MR imaging study was performed 1 year after diagnosis, and subsequent imaging was performed yearly or every 2 years depending on the appearance of new symptoms, tumor growth, or both. RESULTS: Sixty-one patients were lost to follow-up the first year after presentation. Of the 325 patients for whom 1-year follow-up data were available, 39 showed tumor growth > or = 3 mm. Conservative management was discontinued for these 39 patients. The patients who returned for follow-up were evaluated at 1- or 2-year intervals depending on tumor growth. The authors extrapolated to obtain data for 2-year intervals, yielding data for 160, 56, 21, and 8 patients at 3, 5, 7, and 9 years after initial presentation, respectively. The overall mean tumor growth rate (+/-standard deviation) was 1.15 +/- 2.4 mm/year. This rate was estimated by pooling all values of tumor growth that had been determined for all patients and dividing by the total number of "events," with each assessment constituting an event. In 58.6% of patients, the annual tumor growth rate was < 1 mm/year; in 29.2%, 1-3 mm/year; and in 12.2%, > or = 3 mm/ year. The growth rates of intrameatal (1.02 +/- 1.8 mm/year) and extrameatal (1.40 +/- 3.1 mm/year) tumors did not differ significantly. No significant association was found between tumor growth rate and sex, age, initial hearing status, or initial tumor grade. Delay in diagnosis was the only significant factor associated with tumor growth rate. During follow-up, conservative management was discontinued for 77 (23.7%) of the 325 patients for whom at least 12-month follow-up data were available; surgery was performed in 60 (77.9%) and radiation therapy in 17 (22.1%). CONCLUSIONS: The results of this study support the role of a conservative "wait-and-scan" policy of management for small-sized VSs because most have a slow growth rate. Long-term neuroimaging follow-up is needed even with non-growing tumors.