CFDB - Cystic Fibrosis DataBase

Cochrane Database of Systematic Reviews - Cochrane Protocol (ongoing review)

Surgery for nasal polyposis in cystic fibrosis

Study design (if review, criteria of inclusion for studies)

Eligible studies are randomized controlled trials (RCTs) and quasi‐RCTs. (cross‐over trials not considered). Trials that randomize individual participants and also evaluate trials that use within‐participant randomization, if authors find trials that randomize by nasal side.

Participants

Children and adults diagnosed with CF by genetic testing, sweat test or both will be eligible for inclusion. Participants must also be diagnosed with CRS with nasal polyposis, according to clinical findings in line with the European position paper on rhinosinusitis and nasal polyposis (EPOS), as follows: nasal blockage, obstruction, congestion or nasal discharge, facial pain, reduced sense of smell in adults and cough in children. Along with these symptoms, there must be endoscopic or tomographic signs of sinus inflammation (Fokkens 2020). The authors will consider studies including subsets of relevant participants and, if the authors consider these important and they are able to obtain data just for participants who are eligible for inclusion in this review, they will include these data

Interventions

sinus surgery alone or in combination with medical treatment (non‐surgical) compared to medical treatment (non‐surgical) alone

Outcome measures

Primary outcomes: 1) Change in QoL, measured using validated questionnaires (disease‐specific, such as SNOT‐22 (Habib 2015a), Rhinosinusitis Disability Index (RSDI) (Benninger 1997), Cystic Fibrosis Questionnaire Revised (CFQ‐R) (Quittner 2005) and the Chronic Sinusitis Survey (CSS) (Macdonald 2012); and general questionnaires such as EuroQol‐5D (Balestroni 2012)). 2) Complications of surgery (cranial complications, orbital complications, hemostasis operations, blood transfusion, and toxic shock syndrome) 3) Change in lung function (forced expiratory volume in one second (FEV1) % predicted, FEV1 L, forced vital capacity (FVC) % predicted)

Keywords: Nasal Polyps; Respiratory Tract Diseases; non pharmacological intervention - surg;