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
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 p...
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| Format: | Article |
| Language: | English |
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BMC
2021-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05539-4 |
| _version_ | 1797636673168736256 |
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| author | Aleksi Laajala Paulus Tokola Timo J. Autio Timo Koskenkorva Mikko Tastula Pasi Ohtonen Esa Läärä Olli-Pekka Alho |
| author_facet | Aleksi Laajala Paulus Tokola Timo J. Autio Timo Koskenkorva Mikko Tastula Pasi Ohtonen Esa Läärä Olli-Pekka Alho |
| author_sort | Aleksi Laajala |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-03-11T12:37:28Z |
| format | Article |
| id | doaj.art-3572a7d370c94aa68ee210819d296ffa |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-11T12:37:28Z |
| publishDate | 2021-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3572a7d370c94aa68ee210819d296ffa2023-11-05T12:28:57ZengBMCTrials1745-62152021-09-0122111310.1186/s13063-021-05539-4Total 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 trialAleksi Laajala0Paulus Tokola1Timo J. Autio2Timo Koskenkorva3Mikko Tastula4Pasi Ohtonen5Esa Läärä6Olli-Pekka Alho7Department of Otorhinolaryngology and Head and Neck Surgery, Oulu University HospitalDepartment of Otorhinolaryngology and Head and Neck Surgery, Oulu University HospitalDepartment of Otorhinolaryngology and Head and Neck Surgery, Oulu University HospitalDepartment of Otorhinolaryngology and Head and Neck Surgery, Oulu University HospitalDepartment of Otorhinolaryngology and Head and Neck Surgery, Oulu University HospitalDivision of Operative Care, Oulu University HospitalResearch Unit of Mathematical Sciences, University of OuluDepartment of Otorhinolaryngology and Head and Neck Surgery, Oulu University HospitalAbstract 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: NCT04657549https://doi.org/10.1186/s13063-021-05539-4Chronic tonsillitisRecurrent tonsillitisQuality of lifeTreatmentTonsillectomyTonsillotomy |
| spellingShingle | Aleksi Laajala Paulus Tokola Timo J. Autio Timo Koskenkorva Mikko Tastula Pasi Ohtonen Esa Läärä Olli-Pekka Alho 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 Chronic tonsillitis Recurrent tonsillitis Quality of life Treatment Tonsillectomy Tonsillotomy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Chronic tonsillitis Recurrent tonsillitis Quality of life Treatment Tonsillectomy Tonsillotomy |
| url | https://doi.org/10.1186/s13063-021-05539-4 |
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