| Title {1} | Tonsillectomy versus tonsillotomy for recurrent acute tonsillitis in children and adults (TOTO): a randomized open-label multi-center non-inferiority clinical trial |
| Trial registration {2a and 2b}. | German Clinical Trials Register, DRKS00020823, date of registration: 04-September-2020 |
| Protocol version {3} | V 1.1, 08-May-2020 |
| Funding {4} | Study sponsored by the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) |
| Author details {5a} |
Orlando Guntinas-Lichius1,2, Katharina Geißler1, Thomas Asendorf3, Ralf Tostmann2,4, Jan Löhler2,5 1Department of Otorhinolaryngology, Jena University Hospital, Jena, Germany 2The German Study Centre for Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO), Bonn, Germany 3Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany 4Study Center, University Medical Center Göttingen, Göttingen, Germany 5Scientific Institute for Applied ENT-Research (WIAHNO) of the German Professional Association of ENT-Surgeons (BVHNO), Bad Bramstedt, Germany |
| Name and contact information for the trial sponsor {5b} | Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany |
| Role of sponsor {5c} | Study protocol development and study funded by the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA). The choice of the comparators (tonsillotomy versus tonsillectomy) was predetermined by the G-BA. The study sponsor did not influence study design and will not influence the collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The sponsor will not have any authority over any of these activities. |