Background Many clinical guidelines recommend the preoperative administration of Lugol's solution (LS) for patients undergoing thyroidectomy for Graves’ disease (GD), mainly based on low-quality evidence. Our aim was to assess its influence on intra and postoperative outcomes in patients undergoing total thyroidectomy (TT) for GD. Methods We performed a nationwide multicentre randomised controlled trial including euthyroid patients scheduled for TT due to GD. Patients were randomised for either receiving or not preoperative LS. Surgeons were blinded for treatment assignment. The primary outcome was the overall rate of postoperative complications. Secondary outcomes were intraoperative events and permanent morbidity. Results 136 patients were included (68 in each arm), without preoperative differences among groups. The rate of patients who developed any complication was 51.5% in LS arm vs. 50% in controls (p=1). Postoperative hypocalcaemia appeared in 45.6% vs. 38.2% (p=0.487). The rate of postoperative vocal cord palsy was 6.1% vs. 3.3% (p=0.682). Median Thyroidectomy Difficulty Scale score was slightly higher in the LS group (10 vs. 9; p=0.031). No differences among groups were observed regarding surgical time, intraoperative bleeding, gland weight, or the rate of loss of signal in neuromonitoring. Long-term results have not yet been evaluated. Conclusion Preoperative iodine preparation can be safely obviated facing TT for GD, regarding the intraoperative difficulty and postoperative complications. If long-term results sustain these results, current advice for presurgical preparation in GD could be challenged.

Background Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves’ Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. Methods A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery. Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. Conclusions There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. Trial registration ClinicalTrials.gov identifier: NCT03980132.

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