ABSTRACT
BACKGROUND: Endoscopic sinus surgery (ESS) has been used for decades to treat recurrent acute rhinosinusitis episodes (RARS) in adults. RARS results in infectious symptoms, antibiotic courses, sick leaves, and impaired quality of life. Theoretically, the ESS procedure, through improving the drainage of the paranasal sinuses, decreases the symptoms and enhances the quality of life of the RARS patients. Whether this is true has not been reported in a randomized trial yet. METHODS: We conduct a single-center, non-blinded, randomized, 6-month, parallel group superiority clinical study including 80 adult participants referred to surgical treatment for RARS. The participants will either have ESS or conservative medical treatment (control group). The primary outcome will be the difference between the mean disease-specific Sinonasal Outcome Test 22 (quality of life questionnaire) change scores (from baseline to 6 months) of ESS and control group. DISCUSSION: This study will add significant new information to the effect and harms of ESS procedure in the treatment of adults with RARS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04241016 . Registered on 17 January 2020.
Subject(s)
Paranasal Sinuses , Rhinitis , Sinusitis , Adult , Chronic Disease , Endoscopy/adverse effects , Humans , Paranasal Sinuses/diagnostic imaging , Paranasal Sinuses/surgery , Quality of Life , Randomized Controlled Trials as Topic , Rhinitis/diagnosis , Rhinitis/surgery , Sinusitis/diagnostic imaging , Sinusitis/surgery , Treatment OutcomeABSTRACT
BACKGROUND: Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired quality of life (QoL). Theoretically, removing all or part of the altered pathological palatal lymphoid tissue alleviates the symptoms and enhances the QoL. Whether this is true with total or partial tonsillar resection (tonsillectomy (TE) and tonsillotomy (TT), respectively) has not been reported in a randomised trial yet. METHODS: We conduct a multicentre, partly blinded, randomised, 6-month, parallel-group clinical study including 285 adult participants referred to surgical treatment for chronic or recurrent tonsillitis. The participants will either have TE, TT or watchful waiting (WW). The primary outcome will be the difference between the mean disease-specific Tonsillectomy Outcome Inventory-14 (QoL questionnaire) scores at 6 months. Comparison is made firstly between the combined TE+TT and WW groups (superiority analysis), and secondly between the TE and TT groups (non-inferiority analysis). DISCUSSION: This study will add significant new information to the effects and harms of TE and TT procedures in the treatment of adults with chronic or recurrent tonsillitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04657549.
