Orlando Guntinas-Lichius1,2, Katharina Geißler3, Thomas Asendorf4, Ralf Tostmann5,6, Jan Löhler5,7. 1. Department of Otorhinolaryngology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. orlando.guntinas@med.uni-jena.de. 2. The German Study Centre for Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO), Bonn, Germany. orlando.guntinas@med.uni-jena.de. 3. Department of Otorhinolaryngology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. 4. Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany. 5. The German Study Centre for Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO), Bonn, Germany. 6. Study Center, University Medical Center Göttingen, Göttingen, Germany. 7. Scientific Institute for Applied ENT-Research (WIAHNO) of the German Professional Association of ENT-Surgeons (BVHNO), Bad Bramstedt, Germany.
Abstract
BACKGROUND:Tonsillectomy 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. METHODS: TOTO 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. DISCUSSION: TOTO 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 REGISTRATION: German Clinical Trials Register DRKS00020823 . Registered on 04 September 2020.
RCT Entities:
BACKGROUND: Tonsillectomy 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. METHODS:TOTO 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. DISCUSSION: TOTO 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 REGISTRATION: German Clinical Trials Register DRKS00020823 . Registered on 04 September 2020.
Authors: David L Witsell; Laura J Orvidas; Michael G Stewart; Maureen T Hannley; Edward M Weaver; Bevan Yueh; Timothy L Smith; Nira A Goldstein Journal: Otolaryngol Head Neck Surg Date: 2008-01 Impact factor: 3.497
Authors: Isabel Rubie; Catherine Haighton; James O'Hara; Nikki Rousseau; Nick Steen; Deborah D Stocken; Frank Sullivan; Luke Vale; Scott Wilkes; Janet Wilson Journal: Trials Date: 2015-06-06 Impact factor: 2.279