Clinical trial NCT01551914: Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
Official title: Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Thyroid Tumor
Keywords: Ultrasonic scissors
thyroidectomy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
timeFrame: Day 2
Secondary outcomes:
measure: Medico-economic evaluation
timeFrame: Day 0 (Procedure)
measure: Medico-economic evaluation
timeFrame: Day 0 (procedure)
measure: Medico-economic evaluation
timeFrame: Month 6
measure: Medico-economic evaluation
timeFrame: From Day 0 until Month 6
measure: Operative morbidity
timeFrame: Month 6
measure: Operative morbidity
timeFrame: Until Month 6
measure: Operative morbidity
timeFrame: Day 0 to Day 2
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Eric Mirallié, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.