Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Trials

Study Protocol

Paulus Tokola¹  Mikko Tastula¹  Timo Koskenkorva¹  Timo J. Autio¹  Aleksi Laajala¹  Olli-Pekka Alho¹  Pasi Ohtonen²  Esa Läärä³ 

[1] Department of Otorhinolaryngology and Head and Neck Surgery, Oulu University Hospital, P.O. Box 5000, FIN-90014, Oulu, Finland;PEDEGO Research Unit, University of Oulu, Oulu, Finland;Medical Research Center Oulu, Oulu, Finland;Division of Operative Care, Oulu University Hospital, Oulu, Finland;Research Unit of Mathematical Sciences, University of Oulu, Oulu, Finland;

关键词: Chronic tonsillitis;    Recurrent tonsillitis;    Quality of life;    Treatment;    Tonsillectomy;    Tonsillotomy;    Randomised controlled trial;   

DOI  :  10.1186/s13063-021-05539-4

 received in 2021-06-08, accepted in 2021-08-11,  发布年份 2021

来源: Springer

【 摘 要 】

BackgroundTonsillar 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.MethodsWe 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).DiscussionThis 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 registrationClinicalTrials.gov: NCT04657549

【 授权许可】

CC BY   
© The Author(s) 2021. corrected publication 2023

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