A novel electrosurgical divider: performance in a self-controlled tonsillectomy study

Abstract

Purpose: Tonsillectomies are among the most common surgeries in otorhinolaryngology. A novel electrosurgical temperature-controlled instrument (device) promises rapid tonsillectomies and might reduce postoperative pain, but comparative studies to assess performance are warranted.

Methods: This randomized self-controlled clinical trial was conducted from October 2019 to October 2020 at the Department of Otorhinolaryngology, Head and Neck Surgery of the Medical University of Vienna. Forty-eight patients underwent a tonsillectomy with the device on one side and using cold-steel with localized bipolar cauterization on the other side (control). Main outcomes were the time for tonsil removal (per side) and the time to stop bleeding (per side). Secondary measurements were postoperative pain, assessed once on day 0 and five times on days 1, 3, 5, 7, and 10. Postoperative bleeding episodes and consequences were recorded.

Results: Device tonsillectomies were performed significantly faster than controls; the mean surgical time difference was 209 s (p < 0.001, 95% CI 129; 288). Intraoperative blood loss was significantly lower on the device side (all p < 0.05). Postoperative measurements of pain and bleeding were similar for both sides. Two return-to-theatre secondary bleeding events were recorded for the control side.

Conclusion: The novel electrosurgical temperature-controlled divider reduced the tonsillectomy surgical time and intraoperative blood loss, with no apparent negative effects on postoperative pain or bleeding, compared to a cold-steel tonsillectomy with localized bipolar cauterization. In time-restricted settings, the device could be beneficial, particularly after familiarization with device handling.

Trial registration: ClinicalTrials.gov Identifier: NCT03793816.

Keywords: Haemorrhage; Pain; Palatine tonsil; Surgical device; Tonsillitis.

Conflict of interest statement

The authors declare that they have no conflict of interest.

© 2021. The Author(s).

Figures

Fig. 1

Study flowchart shows the patient selection process, tonsil randomization (left/right) procedure, and follow-up assessments

Fig. 2

Tonsillectomy surgical times (s) for the BiZact device side (Device) and for the control cold-steel side (CSB), grouped by surgeon experience (e.g., less than 10 tonsillectomies in their careers, etc.)

Fig. 3

Mean postoperative pain differences between cold-steel (control) and BiZact device sides. Pain was assessed once on day 0, and 5 times per day on several postoperative days (total 26 time points). Symbols indicate the mean difference between pain ratings on the control and device sides (i.e., VAS of device pain–VAS of control pain), and whiskers indicate the 95% confidence intervals. Negative values indicate greater pain on the control side, and positive values indicate greater pain on the device side. VAS: visual analogue scale