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

Conditions

Thyroid Tumor

Keywords

Ultrasonic scissors, thyroidectomy

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).

Claire Blanchard, Sahar Bannani, François Pattou, Laurent Brunaud, A. Hamy et al. (20 authors)

Head & Neck2019-04-1923 citations

10.1002/hed.25773

Advanced age does not increase morbidity after total thyroidectomy. Result of a prospective study.

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, Mirallié E.

2018-07-251 citations

10.1016/j.amjsurg.2018.07.029

Randomized clinical trial of ultrasonic scissors<i>versus</i>conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)

Claire Blanchard, François Pattou, Laurent Brunaud, A. Hamy, M. Dahan et al. (11 authors)

BJS Open2017-02-0124 citations

10.1002/bjs5.2

Interventions

DEVICEUltrasonic Scissors (Ethicon)

Haemostasis using Ultrasonic scissors

DEVICEBipolar Electrosurgical instruments (Medtronic) (SLS- Clips)

bipolar, monopolar or clip coagulation techniques

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame
Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)	Day 2

Secondary

Measure	Time frame	Description
Medico-economic evaluation	Day 0 (Procedure)	Operating time
Operative morbidity	Month 6	Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L

Countries

France

Outcome results

None listed