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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Thyroid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ultrasonic scissors

Group Type EXPERIMENTAL

Ultrasonic Scissors (Ethicon)

Intervention Type DEVICE

Haemostasis using Ultrasonic scissors

conventional techniques of haemostasis

clips, ligatures, and bipolar coagulation

Group Type ACTIVE_COMPARATOR

Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)

Intervention Type DEVICE

bipolar, monopolar or clip coagulation techniques

Interventions

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Ultrasonic Scissors (Ethicon)

Haemostasis using Ultrasonic scissors

Intervention Type DEVICE

Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)

bipolar, monopolar or clip coagulation techniques

Intervention Type DEVICE

Other Intervention Names

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Harmonic Focus scissors (Ethicon) Bipolar Electrosurgical instruments (Medtronic) SLS- Clips

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No