Guidance
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 randomised controlled trial (RCT) of 143 patients treated by minimally invasive video‑assisted parathyroidectomy (MIVAP) or open minimally invasive parathyroidectomy (OMIP) reported cure rates of 97% (66/68) and 96% (72/75) respectively (p=0.731). An RCT of 60 patients treated by MIVAP or OMIP reported that all patients were cured at 6‑month follow-up. A non‑randomised comparative study of 220 patients treated by MIVAP or OMIP reported persistent or recurrent primary hyperparathyroidism in 2% (2/118) of patients in the MIVAP group and in no patients in the OMIP group (p value not reported). A non‑randomised comparative study of 157 patients treated by MIVAP or conventional parathyroidectomy reported recurrence rates of 3% and 4% respectively at 6 months (p=not significant). A case series of 652 patients reported persistent hyperparathyroidism in 1% (6/652) of patients (follow-up period not reported).
4.2 The RCT of 143 patients reported that 25% (17/68) of MIVAP procedures and 17% (13/75) of OMIP procedures were converted to bilateral neck exploration (p=0.26). The non‑randomised comparative study of 220 patients reported that 14% (17/125) of MIVAP procedures were converted to OMIP. The non‑randomised comparative study of 157 patients reported that 5% (4/76) of MIVAP procedures were converted to conventional parathyroidectomy. A case series of 107 patients reported conversion to conventional parathyroidectomy in 8% (8/107) of patients.
4.3 The RCTs of 143 and 60 patients treated by MIVAP or OMIP both reported similar cosmesis scores (visual analogue scale [VAS] 0 to 100, with 100 being the best possible score) in the 2 treatment groups at 6‑month follow-up (92 versus 95 [p=0.411] and 90.5 versus 87.5 [p=0.16] respectively). An RCT of 38 patients reported a significantly higher patient satisfaction score (measured on a scale from 1 [poor] to 10 [excellent]) at 6‑month follow-up in the MIVAP group compared with the conventional parathyroidectomy group (7.5 versus 4.5, p<0.03). A non‑randomised comparative study of 168 patients treated by MIVAP or OMIP reported a significantly higher score for patient satisfaction with the cosmetic result 1 month after surgery in the MIVAP group (85.4 versus 77.4, p=0.01), but the difference in scores was no longer statistically significant after 6 months (90.5 versus 87.5).
4.4 Pain scores at 1 day, 1 week and 4 weeks after surgery (100‑point VAS, with higher scores representing more severe pain) were similar in patients treated by either MIVAP or OMIP in the RCT of 143 patients. Pain scores were significantly lower 24 hours after surgery in patients treated by MIVAP than in patients treated by OMIP in the RCT of 60 patients and the non‑randomised comparative study of 168 patients (15.5 versus 20.4 [p<0.001] and 14.1 versus 19.8 [p<0.001] respectively). Pain scores (10‑point VAS, with higher scores representing more severe pain) were significantly lower in patients treated by MIVAP than in patients treated by conventional parathyroidectomy in the RCT of 38 patients (2 versus 3, 48 hours after surgery, p<0.03) and in the non‑randomised comparative study of 157 patients (2.1 versus 3.6, 24 hours after surgery, p<0.001).
4.5 The specialist advisers listed key efficacy outcomes as rate of normocalcaemia after surgery, cosmesis and patient satisfaction.