Overview

This trial is active, not recruiting.

Condition thyroid tumor
Treatments ultrasonic scissors (ethicon), bipolar electrosurgical instruments (medtronic) (sls- clips)
Phase phase 3
Sponsor Nantes University Hospital
Start date March 2012
End date October 2014
Trial size 1350 participants
Trial identifier NCT01551914, RC11_0148

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ultrasonic scissors (ethicon) Harmonic Focus scissors (Ethicon)
Haemostasis using Ultrasonic scissors
(Active Comparator)
clips, ligatures, and bipolar coagulation
bipolar electrosurgical instruments (medtronic) (sls- clips) Bipolar Electrosurgical instruments (Medtronic)
bipolar, monopolar or clip coagulation techniques

Primary Outcomes

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

Secondary Outcomes

Measure
Medico-economic evaluation
time frame: Day 0 (Procedure)
Medico-economic evaluation
time frame: Day 0 (procedure)
Medico-economic evaluation
time frame: Month 6
Medico-economic evaluation
time frame: From Day 0 until Month 6
Operative morbidity
time frame: Month 6
Operative morbidity
time frame: Until Month 6
Operative morbidity
time frame: Day 0 to Day 2

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
Principal investigator Eric Mirallié, Professor
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Nantes University Hospital.