Table 2.
Early and late complications
|
Ultrasonic scissors (n = 670) |
Conventional haemostasis (n = 659) |
Total (n =1329) |
P § | |
|---|---|---|---|---|
| Intraoperative complications | ||||
| Any complication | 19 (2·8) | 5 (0·8) | 24 (1·8) | 0·008 |
| Device‐related complications† | 2 (0·3) | 0 (0) | 2 (0·2) | |
| Dysfunction of device | 14 (2·1) | 0 (0) | 14 (1·1) | |
| Thyroidectomy could not be performed | 4 (0·6) | 3 (0·5) | 7 (0·5) | |
| Postoperative pain* | 0·241 | |||
| 4 h | 3 (1–4) (n = 618) | 3 (1–4) (n = 614) | 3 (1–4) (n = 1232) | |
| 18–24 h | 2 (0–3) (n = 624) | 2 (0–3) (n = 621) | 2 (0–3) (n = 1245) | |
| Day 2 | 1 (0–2) (n = 574) | 1 (0–2) (n = 563) | (0–2) (n = 1137) | |
| Early postoperative complications | ||||
| Transient hypocalcaemia | 132 (19·7) | 134 (20·3) | 266 (20·0) | 0·743 |
| Haematoma‡ | 6 of 669 (0·9) | 10 of 658 (1·5) | 16 of 1327 (1·2) | 0·306 |
| Time to haematoma (h)* | 2·0 (0·2–6·0) | 2·0 (1·0–3·3) | 2·0 (1·0–4·0) | |
| Dysphonia | 46 of 668 (6·9) | 39 of 658 (5·9) | 85 of 1326 (6·4) | 0·476 |
| Swallowing disorders | 6 of 669 (0·9) | 6 of 658 (0·9) | 12 of 1327 (0·9) | 0·977 |
| Other complications | 12 of 669 (1·8) | 16 of 658 (2·4) | 28 of 1327 (2·1) | 0·401 |
| RLN dysfunction | 66 of 665 (9·9) | 65 of 655 (9·9) | 131 of 1320 (9·9) | 0·996 |
| Hypomotility | 41 | 35 | 76 | |
| Immobility | 25 | 30 | 55 | |
| Complications at 6 months | ||||
| RLN dysfunction | 9 of 632 (1·4) | 3 of 630 (0·5) | 12 of 1262 (1·0) | 0·101 |
| Hypomotility | 5 | 1 | 6 | |
| Immobility | 4 | 2 | 6 | |
| Permanent hypocalcaemia | 16 of 666 (2·4) | 10 of 647 (1·5) | 26 of 1313 (2·0) | –¶ |
Values in parentheses are percentages unless indicated otherwise;
*
values are median (i.q.r.).
†
Skin burning, oral haemorrhage.
‡
Compressive haematoma requiring surgical reoperation. RLN, recurrent laryngeal nerve.
§
Generalized linear mixed model.
¶
In non‐inferiority analysis, mean difference between conventional haemostasis and ultrasonic scissors groups = −0·9 (95 per cent c.i. −2·4 to 0·6) per cent.