Original Title: Eficacia y seguridad de la criocirugía selectiva de los nervios nasales posteriores para el tratamiento sintomático de la rinosinusitis crónica

Authors' objectives: To assess the efficacy and safety of selective posterior nasal nerve cryosurgery with ClariFix® device in the treatment of chronic rhinosinusitis refractory to medical treatment and/or previous surgical interventions.

Authors' results and conclusions: Conclusions Despite the limitations of the included studies, treatment with ClariFix® appears to be effective in reducing symptoms due to rhinosinusitis and reduces the number of post-procedural medications required. It is a safe treatment, with the most common adverse events being post-procedural pain and headache. ClariFix® appears to be an alternative to existing treatments, as it is a fast, minimally invasive procedure that can be performed on an outpatient basis, without the need for general anaesthesia. Methodologically robust comparative clinical trials are needed to compare with standard treatment and to establish efficacy in patients with allergic and non-allergic rhinitis. Factors influencing the success of the intervention need to be studied in order to select the patients who will benefit most from the use of ClariFix®.

Authors' methods: A systematic review of the scientific literature was conducted. Systematic reviews and original articles of randomised clinical trials or observational studies with a comparison and no sample size limitation that met the criteria of the PICO question were included. Editorials, abstracts, conference proceedings, editorials, letters to the editor and non-systematic reviews were excluded. Quality assessment of randomised controlled trials was carried out using the Cochrane RoB 2 tool for risk of bias assessment and the AMSTAR tool for systematic review (SR) assessment. For quality assessment of economic evaluation studies, the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement checklist and the ISPOR-AMCP-NCP tool for relevance and credibility assessment was be used. The outcome measures selected to assess the effectiveness of this report were change in nasal symptom severity measured in the short, medium and long term using specific scales (TNSS, NOSE Score or VAS), as well as change in medication consumption, change in the number of medical visits or improvement in quality of life. For the safety assessment, peri-operative adverse events associated with the technique, the intervention and post-intervention adverse events were considered.

Project Status: Completed

Year Published: 2025

URL for published report: https://hdl.handle.net/20.500.12105/26826

URL for additional information: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=1303

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Esther E. García Carpintero

Contact Email: eegarcia@isciii.es

Copyright: Agencia de Evaluacion de Tecnologias Sanitarias