TOTO study: Is tonsillotomy non-inferior to tonsillectomy in children and adults with recurrent acute tonsillitis?

Tonsillotomy and tonsillectomy are established procedures in ENT. Tonsillotomy is mainly performed in young children with obstructive sleep apnea syndrome, while tonsillectomy is the standard procedure to treat recurrent acute tonsillitis (RAT). So far, it has not been investigated whether tonsillotomy is non-inferior to tonsillectomy for the treatment of patients with RAT over a longer follow-up period. This question should be clarified with the TOTO study (DRKS no.: 00020823) and the current status of the study should be presented. The randomized, multicentre, two-armed, non-blinded, non-inferiority study commissioned by the Federal Joint Committee as a pilot study has been running since November 2020 and is currently being carried out at 21 centers in Germany, with 6 more centers being added in 2023. A total of 454 patients are to be recruited. Children from the age of 3 and adults are included and the indication criteria for surgery in RAT must be fulfilled according to the S2k guideline 017/024. The patients are randomized to receive either a tonsillotomy or a tonsillectomy. The primary outcome parameter is the number of sore throats within 24 months after surgery. The patient is asked about this once a week using the TOTO app. So far, 159 patients have been included. Recruitment has been and will always be made more difficult by the corona pandemic. Educating patients and parents is particularly time-consuming. The tracking of the parameters frequency and treatment of sore throats via the app by the patients or the parents has proven itself.

Gemeinsame Bundesausschuss

Publication History

Article published online:
12 May 2023