A prospective multi-centre randomised controlled trial comparing PlasmaKnife with bipolar dissection tonsillectomy: evaluating an emerging technology

Abstract

Objective: To clinically evaluate and compare the PlasmaKnife to bipolar electrocautery in paediatric tonsillectomy.

Methods: A prospective, multi-centred, double-blinded randomised controlled trial, conducted in central London teaching hospitals. The participants were 100 patients aged 2-16 years with recurrent tonsillitis or obstructive adenotonsillar hypertrophy awaiting a tonsillectomy were recruited in to the study. The primary outcome measures were throat, ear and swallowing pain scores over two weeks. Secondary outcome measures were return to normal diet, return to normal activity, analgesic requirements, operation time and intra-operative blood loss.

Results: Surgical dissection was similar between the two groups with minimal blood loss and comparable overall operative times. We found that PlasmaKnife tonsillectomy caused more throat pain at 24 h (p=0.02). There was a tendency for a higher proportion in the bipolar dissection group to return to a normal diet, at day 3 (p=0.05) and at day 7 (p=0.04). The bipolar dissection returned to normal activities in a larger proportion than the PlasmaKnife group at day 3 (p=0.02) and at day 7 (p=0.01). There is some evidence of an association between use of analgesia at day 14 and method of tonsillectomy (p=0.03); the PlasmaKnife group tended to use less analgesia. During the study, four secondary bleeds occurred in the PlasmaKnife group and one in the bipolar dissection group, and all were managed conservatively.

Conclusion: Our study has found no significant advantage to PlasmaKnife over bipolar diathermy tonsillectomy. However, this preliminary study finds PlasmaKnife to be an interesting instrument and may warrant a larger randomised study to evaluate the potential advantages.