Secondary outcomes
hypocalcaemia, hypoparathyroidism
HYPOCALCAEMIA, POSTOPERATIVE HYPOPARATHYROIDISM, HYPOPARATHYROIDISM
There was no difference between the intervention and control groups regarding duration of operation, central lymph node clearance, treatment with intravenous calcium, duration of hospital stay before discharge, and readmission within 30 days owing to hypocalcaemia (More parathyroid glands were identified during surgery in the FluobeamNumber of parathyroid glands identified in control and intervention groups expressed as a percentage of patientsSome 86 of 486 patients (17.7 per cent) had autotransplantation of at least 1 parathyroid gland, 51 of 246 (20.7 per cent) in the intervention group and 35 of 240 (14.6 per cent) in the control group (Conversely, on final histology, more parathyroid glands were detected in the specimen in the control group: 50 of 240 (20.8 per cent) In the subanalysis of 174 patients who had central lymph node dissection, 6 of 92 (6.5 per cent) in the control group had a parathyroid gland identified in the surgical specimen during surgery compared with 28 of 82 (34.1 per cent) in the intervention group (Some 157 patients (32.3 per cent) were treated for hypoparathyroidism at some point after operation, 79 of 246 (32.1 per cent) in the intervention group (1 patient was lost to follow-up) and 78 of 240 (32.5 per cent) in the control group (Of the 157 patients treated for postoperative hypoparathyroidism, 104 (66.2 per cent) had a low level of PTH, and 53 had a normal or high PTH level on postoperative day 1. Conversely, of the 329 patients not treated for hypoparathyroidism, 37 (11.3 per cent) had a low PTH level, and 292 had a normal or high PTH level. The sensitivity and specificity for a low level of PTH to predict postoperative treatment of hypoparathyroidism at any time after surgery was 66.2 and 88.8 per cent respectively. The positive predictive value was 73.8 per cent.One of the patients treated for hypoparathyroidism, who had been randomized to the intervention group, refused long-term follow-up. All other patients received regular follow-up examinations, with clinical and biochemical evaluation including analysis of calcium and PTH levels. Medical treatment could be terminated within 6 months in 140 of the 156 patients (89.7 per cent) who were followed up according to protocol, and these patients were classified as having temporary hypoparathyroidism. Medical treatment was terminated in 72 of 78 patients in the intervention group (92.3 per cent) and 68 of 78 (87.2 per cent) in the control group.Some 16 patients were treated for hypoparathyroidism for at least 6 months, and thus defined as having permanent hypoparathyroidism according to the study protocol: 6 of 245 (2.4 per cent) in the intervention group and 10 of 240 (4.2 per cent) in the control group (Data for 16 patients treated for hypoparathyroidism for 6 months or more after total thyroidectomyUnless indicated otherwise. PTH, parathyroid hormone.Angiography with ICG for fluorescence during surgery was used in only four patients. Two of these had a low level of PTH on the first day after surgery, and two were treated temporarily for postoperative hypoparathyroidism.