First clinical experience with the BiZact™ tonsillectomy device

Retrospective data analysis of 73 tonsillectomies from 06/2018 to 10/2019 using the BiZact tonsillectomy device at Katholisches Marienkrankenhaus Hamburg.

The following parameter were analyzed: cutting/suture time, intraoperative bleeding (in ml), postoperative pain on 1.-4. postoperative day (numeric rating scale, NRS 0-10), postoperative hemorrhage (primary ≤ 24h, secondary > 24h).

68 patients (≥ 18 a) were included, 76,5 % female, 23,5 % male. The mean age was 27,5 a (range: 18-59a, median: 26). The mean cutting/suture time was 5,6 min (2-12min; 5min). There was no intraoperative bleeding in 55,9 % (38/68), 27,9 % (19/68) ≤ 10ml, 14,7 % (10/68) ≤ 50ml and 1,5 % (1/68) 100ml. For postoperative pain the mean NRS at day 1 was 2,67 (0-7; 3); day 2: 2,74 (0-7; 3); day 3: 2,95 (0-7; 3); day 4: 3,11 (0-6;3). There was no primary post-tonsillectomy hemorrhage. The follow up for secondary bleeding was possible for just 52 patients. The rate of secondary bleeding which needed further intervention was 15,4 % (8/52).

Tonsillectomy using the BiZact tonsillectomy device is a fast procedure with a low level of intraoperative bleeding and comparatively little postoperative pain. In literature there is a higher level of postoperative pain and longer operation time (median: 24 min) for tonsillectomy by cold dissection (Guntinas-Lichius et al. 2016). So far, our analysis shows a rate of post-tonsillectomy hemorrhage of 15,4 %. The Austrian Tonsil Study (Sarny S et al. 2012) showed a rate of post-tonsillectomy hemorrhage of 14,4 %.

There are no statisticly significant finding from this first clinical observation study of 68 patients. The next step should be a randomized controlled trial comparing the outcome of tonsillectomy by cold dissection and BiZact tonsillectomy device.

Poster-PDF A-1342.PDF

Publication History

Article published online:
10 June 2020