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Cold steel versus impedance-dependent tissue sealer tonsillectomy - a study protocol for a randomised controlled
Line Schiøtt Nissen1, Jannik Bertelsen1, Nina Munk Lyhne2
1University Clinic for Balance, Flavour and Sleep, ENT Department, Regionshospital Gødstrup.
Danish Medical Journal
|November 29, 2023
Summary
This study compares cold steel tonsillectomy with a new device to reduce post-tonsillectomy bleeding (PTH). It aims to determine if the new impedance-dependent tissue sealer (IDTS) is safer and more effective for patients undergoing tonsillectomy.
Area of Science:
- Otolaryngology
- Surgical Innovation
- Clinical Trials
Background:
- Tonsillectomy is a common procedure with a significant risk of post-tonsillectomy bleeding (PTH).
- The established cold steel technique has a 7.9% PTH risk in Denmark.
- A novel impedance-dependent tissue sealer (IDTS) shows promise for reducing bleeding and operation time.
Purpose of the Study:
- To compare the efficacy and safety of cold steel tonsillectomy versus the IDTS device.
- To evaluate the incidence of post-tonsillectomy bleeding (PTH) between the two surgical methods.
- To assess secondary outcomes including pain, recovery time, and quality of life.
Main Methods:
- A randomized, controlled, double-blinded, multicenter trial involving 1,250 patients.
- Primary endpoints include PTH, perioperative bleeding, operation time, and post-operative pain.
- Secondary outcomes assess return to work, food intake, activity, and quality of life.
Main Results:
- Preliminary results suggest IDTS may reduce operation time, perioperative bleeding, and post-operative bleeding risk by 4.5%.
- The study is registered under NCT05270109.
- This trial represents the largest randomized controlled trial in ENT surgery in the Nordic countries.
Conclusions:
- The study will provide crucial evidence on the effectiveness of IDTS compared to cold steel tonsillectomy for PTH.
- Findings could influence future tonsillectomy surgical techniques and patient outcomes.
- This research addresses a significant clinical question in otolaryngology.
