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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasonic scissors | Experimental |
| |
| conventional techniques of haemostasis | Active Comparator | clips, ligatures, and bipolar coagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic Scissors (Ethicon) | Device | Haemostasis using Ultrasonic scissors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2) | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Medico-economic evaluation | Operating time | Day 0 (Procedure) |
| Medico-economic evaluation | Cost of the two techniques by microcosting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Mirallié, Professor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Nantes | Nantes | 44000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30055804 | Derived | Christou N, Blanchard C, Pattou F, Volteau C, Brunaud L, Hamy A, Dahan M, Prades JM, Landecy G, Dernis HP, Lifante JC, Sebag F, Jegoux F, Babin E, Bizon A, Caillard C, Mathonnet M, Mirallie E. Advanced age does not increase morbidity after total thyroidectomy. Result of a prospective study. Am J Surg. 2019 Apr;217(4):767-771. doi: 10.1016/j.amjsurg.2018.07.029. Epub 2018 Jul 25. | |
| 29951599 |
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| Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips) | Device | bipolar, monopolar or clip coagulation techniques |
|
|
| 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 |
| Derived |
| Blanchard C, Pattou F, Brunaud L, Hamy A, Dahan M, Mathonnet M, Volteau C, Caillard C, Durand-Zaleski I, Mirallie E; FOThyr Group. Randomized clinical trial of ultrasonic scissors versus conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr). BJS Open. 2017 May 9;1(1):2-10. doi: 10.1002/bjs5.2. eCollection 2017 Feb. |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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