319 [18F]FDG-PET/CT to prevent futile surgery: a blinded, randomised controlled multicentre trial 4 Table 8. Secondary outcomes [18F]FDG-PET/CT-driven group (n=91) diagnostic surgery group (n=41) p adjusted p adjusted OR (95% CI) Surgical complications following diagnostic surgery 13 (14%) 10 (24%)* 0.16e 0.17g 0.5 (0.2-1.3)g in benign nodules (n=98) 9 (14%) 9 (26%) 0.16e 0.23g 0.5 (0.2-1.5)g in malignant and borderline nodules (n=34) 4 (14%) 1 (17%) 1f 0.75g 1.6 (0.1-30.7)g Type of complication Wound infection 1 (1%) 1 (2%) 0.53f 0.62g 0.5 (0.0-8.4)g Hematoma with re-exploration surgery 1 (1%) 1 (2%)a 0.53f 0.53g 0.4 (0.0-7.8)g Seroma 1 (1%) 1 (2%) 0.53f 0.63g 0.5 (0.0-8.7)g Recurrent nerve paralysis 2 (2%) 0 (0%) 1f 1g 2.4E+7 (0-ω)g Hypothyroidism following partial thyroidectomyb 5 (6%)c 7 (17%)a 0.06f 0.07g 0.3 (0.1-1.1)g Hypoparathyroidism, transient 3 (3%)d 1 (2%) 1f 0.85g 1.2 (0.1-13.2)g Survival after one year 91 (100%) 41 (100%) n.a. n.a. n.a. CI=confidence interval. N.a.= not applicable. N.s.=not specified. OR=odds ratio. a: two complications (hematoma and hypothyroidism) occurred in one patient. b: Hypothyroidism due to partial thyroidectomy included patients who had new levothyroxine-dependent hypothyroidism following a partial thyroidectomy procedure (i.e., hemithyroidectomy and/or isthmus resection). c: initial total thyroidectomies (n=5) are excluded from the denominator. d: transient hypoparathyroidism only occurred following initial total thyroidectomy. e: Pearson’s chi-squared test. f: Fisher’s exact test. g: binary logistic regression to adjust for stratifying variables.
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