Cold steel versus impedance-dependent tissue sealer tonsillectomy – a study protocol for a randomised controlled trial

Line Schiøtt Nissen, Jannik Bertelsen, Nina Munk Lyhne, Susanne Holm Nielsen, Pernille Hahn, Jesper Holm, Therese Ovesen

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Abstract

INTRODUCTION. Approximately 7,000 tonsillectomies are performed annually in Denmark on a benign basis. The cold steel surgical technique is the gold standard. The risk of post tonsillectomy bleeding (PTH) in a centre in Jutland is 7.9%. A new impedance-dependent tissue sealer (IDTS) device has been developed, with preliminary results showing a reduction in operation time, perioperative bleeding and post-operative risk of bleeding of 4.5%.

METHODS. A randomised, controlled, double-blinded multicentre trial of cold steel tonsillectomy versus IDTS will be performed on 1,250 patients. The main endpoint is PTH, perioperative bleeding, operation time and post-operative pain. The secondary outcomes are days until return to work, food intake, activity and quality of life. Included in the study are patients with indication for surgery weighing ≥ 16 kg, and excluded are patients with malignancy, bleeding disorders and unwillingness to participate in the study.

CONCLUSIONS. To our knowledge, the present study is the largest randomised controlled trial in ENT surgery in the Nordic countries. The study will potentially provide evidence on PTH regarding two tonsillectomy methods.

FUNDING. The authors have no potential conflicts of interest to declare. The study is supplied with instruments from Medtronic needed for the surgical procedures. Furthermore, a minor part of the funding of the entire project is provided by the aforementioned company. The funding providers have no role in design or conduct of the study.

TRIAL REGISTRATION. Clinicaltrials.gov with the identification number NCT05270109.
Original languageEnglish
Article numberA06230366
JournalDanish Medical Journal
Volume70
Issue number12
ISSN2245-1919
Publication statusPublished - 23. Nov 2023

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