Randomized clinical trial of ultrasonic scissors versus conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)

C Blanchard, F Pattou, L Brunaud, A Hamy, M Dahan, M Mathonnet, C Volteau, C Caillard, I Durand-Zaleski, E Mirallié, FOThyr Group, V-P Riche, S Mucci, C Nominé, R Caiazzo, J M Prades, G Landecy, H P Dernis, J C Lifante, F Sebag, F Jegoux, E Babin, A Bizon, F Espitalier, C Blanchard, F Pattou, L Brunaud, A Hamy, M Dahan, M Mathonnet, C Volteau, C Caillard, I Durand-Zaleski, E Mirallié, FOThyr Group, V-P Riche, S Mucci, C Nominé, R Caiazzo, J M Prades, G Landecy, H P Dernis, J C Lifante, F Sebag, F Jegoux, E Babin, A Bizon, F Espitalier

Abstract

Background: The benefits of single-use ultrasonic scissors in thyroid surgery are still debated. Although this device has been shown to reduce operating time compared with conventional haemostasis, its cost-effectiveness has never been demonstrated. The aim of this study was to evaluate the efficacy, cost-effectiveness and safety of ultrasonic scissors for total thyroidectomy.

Methods: This was a prospective, randomized, multicentre trial conducted at 13 hospital sites. The primary endpoint was the percentage of patients with hypocalcaemia (serum calcium level below 2 mmol/l) on day 2. Secondary endpoints included postoperative complications and costs, with calculation of incremental cost differences and cost-effectiveness ratios.

Results: In total, 1329 patients who underwent total thyroidectomy were included in the analysis: 670 were randomized to treatment with ultrasonic scissors and 659 to conventional haemostasis. There was no difference between groups in the rate of complications, including hypocalcaemia on day 2 (19.7 per cent in ultrasonic scissors group versus 20.3 per cent in conventional haemostasis group; P = 0·743). Median operating times were significantly shorter with ultrasonic scissors (90 versus 100 min with conventional haemostasis; P < 0·001). Total mean(s.d.) direct costs at 6 months were €4311(1547) and €4011(1596) respectively (P < 0·001).

Conclusion: Ultrasonic scissors were no more clinically effective than conventional haemostasis, but use of these devices was more costly. Registration number: NCT01551914 (http://www.clinicaltrials.gov).

Figures

Figure 1
Figure 1
CONSORT flow chart for the trial. FAS, full analysis set; PP, per protocol
Figure 2
Figure 2
a Uncertainty associated with the immediate cost‐effectiveness of ultrasonic shears shown as a scatter plot of differences in mean cost and immediate hypocalcaemia between the two techniques. b Uncertainty associated with the 6‐month cost‐effectiveness of ultrasonic shears shown as a scatter plot of differences in mean cost and postoperative complications between the two techniques

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Source: PubMed

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