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 Unilateral vocal cord paresis was reported in 3% (2/68) of patients treated by minimally invasive video‑assisted parathyroidectomy (MIVAP) and 1% (1/75) of patients treated by open minimally invasive parathyroidectomy (OMIP) in a randomised controlled trial (RCT) of 143 patients (p value not reported). This resolved within 3 months in the 2 patients treated by MIVAP but was still present 6 months after surgery in the patient treated by OMIP. Laryngeal nerve palsy 6 months after surgery was reported in 1 patient treated by MIVAP and no patients treated by conventional parathyroidectomy in an RCT of 38 patients. Transient recurrent laryngeal nerve palsy was reported in 1% (1/100) and 3% (2/68) of patients treated by MIVAP or OMIP respectively in a non‑randomised comparative study of 168 patients (p=not significant). Permanent recurrent laryngeal nerve palsy was reported in 1% (1/107, and 4/652) of patients in 2 case series of 107 and 652 patients respectively.

5.2 Postoperative bleeding that needed reoperation was reported in 1 patient in the case series of 652 patients (caused by a displaced clip on a middle thyroid vein).

5.3 Symptomatic transient hypocalcaemia after the procedure was reported in 3% (1/30) and 7% (2/30) of patients treated by MIVAP and OMIP respectively in an RCT of 60 patients, and in 5% (1/20) and 17% (3/18) of patients treated by MIVAP and conventional parathyroidectomy respectively in the RCT of 38 patients (p values not reported). Symptomatic hypocalcaemia was reported in 13% (14/107) of patients in the case series of 107 patients (2 patients needed vitamin D supplementation).

5.4 The specialist advisers listed additional theoretical adverse events as infection, injury to local neuro-vascular structures or trachea/oesophagus.

  • National Institute for Health and Care Excellence (NICE)