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

Nantes University Hospital (NUH)

Status and phase: Unknown; Phase 3

Conditions: Thyroid Tumor

Treatments: Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips); Device: Ultrasonic Scissors (Ethicon)

Study type: Interventional

Funder types: Other

Identifiers

NCT01551914

RC11_0148

Details and patient eligibility

About

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).

Enrollment: 1,350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,350 participants in 2 patient groups

ultrasonic scissors

Experimental group

Treatment:

Device: Ultrasonic Scissors (Ethicon)

conventional techniques of haemostasis

Active Comparator group

Description:

clips, ligatures, and bipolar coagulation

Treatment:

Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)