Abstract
BackgroundTonsillectomy is one of the most frequently performed surgeries in children and young adults worldwide. For decades, tonsillectomy was the surgical treatment of choice for recurrent acute tonsillitis. Tonsillotomy was used in some countries as an alternative to tonsillectomy only for the treatment of obstructive sleep apnea in young children. In recent years, an increase of tonsillotomy also to treat recurrent acute tonsillitis can be observed. Therefore, the German Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether tonsillotomy offers advantages compared to tonsillectomy. The meta-analysis of the IQWiG including studies until 2016 revealed that the long-term benefits and harms of tonsillotomy compared to tonsillectomy are unclear. Consequently, the G-BA performed a European call for a clinical trial. A consortium of the German Professional Association of ENT-surgeons (BVHNO), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), and the Jena University Hospital were finally selected to perform the TOTO study.MethodsTOTO is a multicenter, 1:1 two-arm, randomized non-blinded non-inferiority trial. Four hundred fifty-four patients ≥ 3 years of age will be randomly allocated to undergo either tonsillotomy or tonsillectomy as surgical treatment of recurrent acute tonsillitis. All participants will be followed up for a total of 24 months. The primary outcome is the number of sore throat days experienced over the 24-month follow-up.DiscussionTOTO is designed to evaluate the effectiveness and efficiency of tonsillectomy versus tonsillectomy for the management of patients with recurrent acute tonsillitis. Tonsil disease and surgery have a major impact on preschool and school children as well as on economically active young adults, with individual and societal costs through loss of school visits, earnings, and productivity. If tonsillotomy is at least as effective as tonsillectomy but with reduced morbidity, this would reduce costs to the healthcare system and society.Trial registrationGerman Clinical Trials Register DRKS00020823. Registered on 04 September 2020.
Highlights
Background and rationale {6a} Tonsil surgery still is one of the most frequent otolaryngological surgeries, especially in children and young adults
The Austrian Societies of Otorhinolaryngology, Head and Neck Surgery and Paediatrics published in 2013 the results of a nationwide multicenter study on tonsil surgery based on the release of a consensus paper with clear recommendations for tonsil surgery from 2007 [3]
Plans for communicating important protocol amendments to relevant parties {25} Any modifications to the protocol which may impact on the conduct of the study, a potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such an amendment will be agreed upon by trial steering committee (TSC) and the sponsor and approved by the Discussion Scronym of the trial (TOTO) follows a public contract by the G-BA, the highest decision-making body for joint self-government in the German healthcare system
Summary
Background and rationale {6a} Tonsil surgery still is one of the most frequent otolaryngological surgeries, especially in children and young adults. This report observed a very high regional variance in the number of tonsil surgeries. An important subsequent step was the introduction of the clinical guideline “Therapy of inflammatory conditions of the tonsils tonsillitis” under the leadership of the German Society for Ear, Nose, and Throat, Head and Neck Surgery in 2015 [4]. This guideline defined clear recommendations for an indication for tonsil surgery in case of recurrent acute tonsillitis. NATTINA is a multicenter, randomized, controlled trial for adults with recurrent tonsillitis to compare the clinical and cost-effectiveness of tonsillectomy versus conservative management. Tonsillectomy is one of the most frequently performed surgeries in children and young adults worldwide. An increase of tonsillotomy to treat recurrent acute tonsillitis can be observed. A consortium of the German Professional Association of ENT-surgeons (BVHNO), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), and the Jena University Hospital were selected to perform the TOTO study
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