University of Oulu

Laajala, A., Tokola, P., Autio, T.J. et al. 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 22, 617 (2021). https://doi.org/10.1186/s13063-021-05539-4

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

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Author: Laajala, Aleksi1,2,3; Tokola, Paulus1,2,3; Autio, Timo J.1,2,3;
Organizations: 1Department of Otorhinolaryngology and Head and Neck Surgery, Oulu University Hospital, P.O. Box 5000, FIN-90014, Oulu, Finland
2PEDEGO Research Unit, University of Oulu, Oulu, Finland
3Medical Research Center Oulu, Oulu, Finland
4Division of Operative Care, Oulu University Hospital, Oulu, Finland
5Research Unit of Mathematical Sciences, University of Oulu, Oulu, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 1 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2021112456717
Language: English
Published: Springer Nature, 2021
Publish Date: 2021-11-24
Description:

Abstract

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.

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Series: Trials
ISSN: 1745-6215
ISSN-E: 1745-6215
ISSN-L: 1745-6215
Volume: 22
Issue: 1
Article number: 617
DOI: 10.1186/s13063-021-05539-4
OADOI: https://oadoi.org/10.1186/s13063-021-05539-4
Type of Publication: A1 Journal article – refereed
Field of Science: 3126 Surgery, anesthesiology, intensive care, radiology
3125 Otorhinolaryngology, ophthalmology
Subjects:
Funding: This is an investigator-initiated study. The participants’ communities finance the clinical visits and treatments with a small deductible paid by the participants. The hospital and university pay the participating physicians’ salaries as usual, and they do the research work as part of their daily work. The more extensive scientific work done mainly by the doctoral students (AL, PT) is covered by governmental financing granted for this research project for 2021 and also sought for 2022–2023. (Additional file 2) Otherwise, we receive no financial, material or other support for this work.
Copyright information: © The Author(s). 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
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