Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy

Study Overview
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Brief Summary
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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).

Official Title
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Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy

Conditions
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Thyroid Tumor

Intervention / Treatment
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* Device: Ultrasonic Scissors (Ethicon)
* Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 18 yrs With a toxic goiter or not, Graves' disease or thyroid nodule requiring a total thyroidectomy Thyroidectomy under cervicotomy No echographic criteria to suspect a cancer: poorly defined nodules, microcalcifications, cervical nodes Patient covered by social security Patient's informed and written consent Possible follow-up during 6 months Exclusion Criteria: Minors and adults under guardianship Preoperatively known thyroid cancer by cytology Planned partial thyroidectomy Peri-operatively antiplatelet intake Preoperatively ENT examination (if performed) finding a vocal cords affection Diving goiter (> 3 cm below the sternal notch) Surgery using videoscopy Lack of possible monitoring during the 6 months after surgery History of anterior cervical surgery Pregnancy and breast-feeding hypercalcemia (calcemia> 2.6 mmol/l)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasonic scissors<br> | Device: Ultrasonic Scissors (Ethicon)<br>* Haemostasis using Ultrasonic scissors<br>* Other names: Harmonic Focus scissors (Ethicon);|
| Active Comparator: conventional techniques of haemostasis<br>clips, ligatures, and bipolar coagulation | Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)<br>* bipolar, monopolar or clip coagulation techniques<br>* Other names: SLS- Clips;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2) |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medico-economic evaluation | Operating time | Day 0 (Procedure) | 
| Medico-economic evaluation | Cost of the two techniques by microcosting | Day 0 (procedure) | 
| Medico-economic evaluation | Total cost at month 6 | Month 6 | 
| Medico-economic evaluation | Incremental cost effectiveness ratio | From Day 0 until Month 6 | 
| Operative morbidity | Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L | Month 6 | 
| Operative morbidity | Recurrent disease | Until Month 6 | 
| Operative morbidity | Hemorrhagic disease | Day 0 to Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonic scissors, thyroidectomy