4 Efficacy

4 Efficacy

This section describes efficacy 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.

4.1 A non-randomised comparative study of 234 patients with papillary thyroid cancer treated by minimally invasive video‑assisted thyroidectomy (MIVAT) or conventional (open) thyroidectomy reported that 87% (148/171) and 76% (38/50) of patients respectively were disease-free at mean follow-up of 3.6 years (no significant difference). There were no recurrences and no thyroid cancer-related deaths in either group. A non-randomised comparative study of 68 patients with papillary thyroid microcarcinoma treated by MIVAT or conventional thyroidectomy reported that there were no recurrences and no thyroid cancer-related deaths in either group during a mean follow-up of 5 years. A mixed case series of 300 patients with benign or malignant thyroid disease reported no recurrences after a mean follow-up of 12 months.

4.2 The non-randomised comparative study of 234 patients with papillary thyroid cancer reported that 7% (13/184) of MIVAT procedures were converted to conventional thyroidectomy. A case series of 833 patients reported that 2% (16/833) of MIVAT procedures were converted to conventional thyroidectomy. The case series of 300 patients reported that MIVAT was converted to open thyroidectomy in 1% (2/300) of patients with benign thyroid nodules and in 6% (18/300) of patients with malignancy, after frozen sections revealed differentiated thyroid carcinoma.

4.3 A systematic review of 9 studies including 581 patients, which compared 289 patients treated by MIVAT against 292 patients treated by conventional thyroidectomy for thyroid nodular disease, reported that pain scores (measured on a 10‑point visual analogue scale [VAS], with higher scores indicating more severe pain) were lower 24 and 48 hours after surgery in patients treated by MIVAT than in those treated by conventional thyroidectomy (outcome reported in 5 studies; VAS at 24 hours 1.69 versus 3.39, standardised mean difference [SMD] −3.101, 95% confidence interval [CI] −4.840 to −1.361; VAS at 48 hours 1.05 versus 2.45, SMD −2.571, 95% CI −4.247 to −0.896, p<0.0001). There were no statistically significant differences 6 hours after surgery. A non-randomised comparative study of 982 patients with benign or malignant thyroid disease reported that pain scores were significantly lower 36 hours after surgery in patients treated by MIVAT than in patients treated by conventional thyroidectomy (1.1 versus 1.9, p<0.05).

4.4 The non-randomised comparative study of 982 patients reported higher satisfaction scores (scale 0–10, with higher scores being better) for MIVAT and for minimally invasive open thyroidectomy (using a smaller incision than conventional thyroidectomy) compared with conventional thyroidectomy (7, 8 and 5 respectively, p<0.05). A randomised study of 62 patients treated by MIVAT or robot-assisted transaxillary thyroidectomy reported significantly lower appearance and satisfaction with appearance scores on the Patient Scar Assessment Questionnaire (higher scores indicating poorer outcomes) in the MIVAT group (appearance score: 14 versus 17, p<0.0001; satisfaction with appearance score: 12 versus 16, p<0.018). The same study also reported significantly higher scores for the SF‑36 domain of bodily pain (98 versus 81, p<0.0005) but lower scores for the SF‑36 domains of social functioning (74 versus 90, p<0.006) and general health (79 versus 91, p<0.0001) in the MIVAT group (higher scores indicate less disability).

4.5 Voice and swallowing alterations scores (measured on a 10-point visual analogue scale, with 10 representing the worst possible outcome) 24 hours after surgery were significantly lower for patients treated by MIVAT than for patients treated by conventional thyroidectomy (1.5 versus 3.0, p<0.01) in the non‑randomised comparative study of 68 patients.

4.6 The specialist advisers listed key efficacy outcomes as reduced pain after surgery, cosmesis and patient satisfaction.

  • National Institute for Health and Care Excellence (NICE)