5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Overall postoperative morbidity rates (not further defined) of 10% (29/289) and 14% (42/292) were reported for minimally invasive video‑assisted thyroidectomy (MIVAT) and conventional (open) thyroidectomy respectively (pooled odds ratio 0.65, 95% confidence interval 0.387 to 1.091, p=0.544) in a meta-analysis of  9 studies including 581 patients (outcome reported in 7 studies).

5.2 Definitive monolateral recurrent laryngeal nerve palsy was reported in 1% (7/833), 2% (5/300) and 2% (2/116) of patients in case series of 833, 300 and 116 patients treated with MIVAT respectively.

5.3 Superior laryngeal nerve injury was reported in 2% (5/300) of patients in the case series of 300 patients.

5.4 Postoperative bleeding that needed reoperation was reported in less than 1% (1/833) and 4% (5/116) of patients in the case series of 833 and 116 patients respectively.

5.5 Wound sepsis was reported in less than 1% (2/833) of patients in the case series of 833 patients.

5.6 Permanent hypoparathyroidism was reported in 6% (2/34) of patients treated by MIVAT and 6% (4/65) of patients treated by conventional thyroidectomy in a non‑randomised comparative study of 99 patients. Severe symptomatic hypoparathyroidism was reported in 2% (2/116) of patients in the case series of 116 patients.

5.7 Transient postoperative hypocalcaemia was reported in 4% (12/289 and 11/292) of patients treated by either MIVAT or conventional thyroidectomy respectively (p=0.9) in the systematic review of 9 studies including 581 patients (outcome reported in 5 studies). Permanent hypocalcaemia needing substitutive therapy was reported in less than 1% (2/510 total thyroidectomies) of patients in the case series of 833 patients.

5.8 A skin burn was reported in 2% (5/300) of patients in the case series of 300 patients.

5.9 The specialist advisers listed the additional adverse event of neck haematoma.

  • National Institute for Health and Care Excellence (NICE)