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

Thyroid Tumor Clinical Trial

— FOThyr  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01551914
• Other study ID #: RC11_0148
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 23, 2012
• Last updated: June 30, 2014
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1350
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Tumor

Intervention

Device:
• Ultrasonic Scissors (Ethicon)
Haemostasis using Ultrasonic scissors
• Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
bipolar, monopolar or clip coagulation techniques

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)		Day 2	No
Secondary	Medico-economic evaluation	Operating time	Day 0 (Procedure)	No
Secondary	Medico-economic evaluation	Cost of the two techniques by microcosting	Day 0 (procedure)	No
Secondary	Medico-economic evaluation	Total cost at month 6	Month 6	No
Secondary	Medico-economic evaluation	Incremental cost effectiveness ratio	From Day 0 until Month 6	No
Secondary	Operative morbidity	Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L	Month 6	No
Secondary	Operative morbidity	Recurrent disease	Until Month 6	No
Secondary	Operative morbidity	Hemorrhagic disease	Day 0 to Day 2	Yes