The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,350
Haemostasis using Ultrasonic scissors
bipolar, monopolar or clip coagulation techniques
CHU Nantes
Nantes, Nantes, France
Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
Time frame: Day 2
Medico-economic evaluation
Operating time
Time frame: Day 0 (Procedure)
Medico-economic evaluation
Cost of the two techniques by microcosting
Time frame: Day 0 (procedure)
Medico-economic evaluation
Total cost at month 6
Time frame: Month 6
Medico-economic evaluation
Incremental cost effectiveness ratio
Time frame: From Day 0 until Month 6
Operative morbidity
Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L
Time frame: Month 6
Operative morbidity
Recurrent disease
Time frame: Until Month 6
Operative morbidity
Hemorrhagic disease
Time frame: Day 0 to Day 2
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