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

Phase 3

• Conditions: Thyroid Tumor
• Interventions: Device: Ultrasonic Scissors (Ethicon); Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)

• Registration Number: NCT01551914
• Lead Sponsor: Nantes University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01
• Primary Completion: 2014-10
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1350

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasonic scissors	Ultrasonic Scissors (Ethicon)	-
conventional techniques of haemostasis	Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)	clips, ligatures, and bipolar coagulation

Primary Outcome Measures

Name	Time	Method
Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)	Day 2

Secondary Outcome Measures

Name	Time	Method
Operative morbidity	Day 0 to Day 2	Hemorrhagic disease
Medico-economic evaluation	From Day 0 until Month 6	Incremental cost effectiveness ratio

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France