NCT01551914

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,350 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Thyroid Tumor

Interventions

Type	Name	Description
DEVICE	Ultrasonic Scissors (Ethicon)	Haemostasis using Ultrasonic scissors
DEVICE	Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)	bipolar, monopolar or clip coagulation techniques

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-10-01
• Completion: 2015-03-01
• First posted: 2012-03-13
• Last updated: 2014-07-01

Locations

1 site across 1 country: France