Follow-up
Tg/LT4, Anxiety, Subjective dysphagia, dysphonia, nerve paralysis, Subjective dysphonia
DYSPHAGIA, POSTOPERATIVE COMPLICATIONS, HYPOPARATHYROIDISM, NERVE PARALYSIS, REMISSION, POST-OP COMPLICATION
All patients will have a postoperative visit within 4 months of the surgery with the surgeon to record post-op complications.For all patients, Tg/LT4 and anti-Tg antibodies (anti-Tg Ab) measured 8 +/−2 weeks postoperatively, before stimulation with recombinant human thyrotropin (rhTSH).At 8 +/− 2 weeks post-op before 131I:-Quality of life (SF-36) [-EQ-5D 3 Levels [-Anxiety (State-Trait Anxiety Inventory) [-Subjective dysphagia (measured via the SWAL-QOL questionnaire) [For all patients (after 2 months but within 4 months postoperatively at the time of 131I administration:Stimulated usTg (Tg/rhTSH), anti-Tg antibodies (anti-Tg Ab)Neck ultrasoundWhole body scintiscan with SPECT performed 2–5 days after the RAI administrationQuality control of total thyroidectomy will be ensured by calculation of the % of 131I uptake, as an estimate of the size of thyroid remnant.Further follow-up consists in:1 year after surgery (8 +/− 2 months after 131I) (primary endpoint): usTg on thyroxine treatment (usTg/LT4) with a standard ultrasensitive kit, anti-Tg Ab, neck ultrasoundYearly for 5 years (+/− 2 months after 131I): Tg/LT4, anti-Tg Ab, neck ultrasoundIf suspicious lesion (according to standardized criteria on ultrasound [If a suspicious lesion <8mm is visualized on ultrasound (according to standardized criteria,[Functional evaluation and quality of life:Immediate postoperative complications (0–4 months after surgery) (hypoparathyroidism requiring supplementation, recurrent nerve paralysis visualized on systematic laryngoscopy)Complications at 1 year: treatment for persistent hypoparathyroidism, recurrent nerve paralysis visualized on systematic laryngoscopy performed at 1 yearAt 1 year after randomization: Subjective dysphonia (measured via the Voice Handicap Index [Complete remission at 1, 3, and 5 years after randomizationAt 1, 3, and 5 years after randomization: Quality of life [SF-36 + EQ-5D], Anxiety (State-Trait Anxiety Inventory), all questionnaires in their validated French translation:Quality of life (SF-36) [EQ-5D 3 Levels [Anxiety (State-Trait Anxiety Inventory) [Subjective dysphonia (measured via the Voice Handicap Index, VHI) [Subjective dysphagia (measured via the SWAL-QOL questionnaire) [