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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 ( IF 2.5 ) Pub Date : 2021-09-15 , DOI: 10.1186/s13063-021-05539-4
Aleksi Laajala 1, 2, 3 , Paulus Tokola 1, 2, 3 , Timo J Autio 1, 2, 3 , Timo Koskenkorva 1, 2, 3 , Mikko Tastula 1, 2, 3 , Pasi Ohtonen 4 , Esa Läärä 5 , Olli-Pekka Alho 1, 2, 3
Affiliation  

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. 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). 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. ClinicalTrials.gov: NCT04657549

中文翻译:

全部或部分扁桃体切除术(扁桃体切除术或扁桃体切开术)以改变患有复发性或慢性扁桃体炎的成人的生活质量:随机对照试验的研究方案

几十年来,扁桃体手术一直用于治疗成人复发性和慢性扁桃体炎。复发性和慢性扁桃体炎会导致令人不安的症状、治疗费用、病假和生活质量 (QoL) 受损。理论上,去除全部或部分改变的病理性腭淋巴组织可以减轻症状并提高生活质量。随机试验尚未报告全部或部分扁桃体切除术(分别为扁桃体切除术(TE)和扁桃体切开术(TT))是否属实。我们进行了一项多中心、部分盲法、随机、为期 6 个月的平行组临床研究,包括 285 名因慢性或复发性扁桃体炎接受手术治疗的成年参与者。参与者将进行 TE、TT 或观察等待 (WW)。主要结果将是 6 个月时疾病特异性扁桃体切除结果调查表 14(生活质量问卷)平均评分之间的差异。首先在 TE+TT 组合组和 WW 组之间进行比较(优越性分析),然后在 TE 和 TT 组之间进行比较(非劣效性分析)。这项研究将为 TE 和 TT 手术治疗成人慢性或复发性扁桃体炎的影响和危害添加重要的新信息。ClinicalTrials.gov:NCT04657549
更新日期:2021-09-15
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