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

June 30, 2014 updated by: Nantes University Hospital
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • CHU Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasonic scissors
Device: Ultrasonic Scissors (Ethicon)
Haemostasis using Ultrasonic scissors
Other Names:
  • Harmonic Focus scissors (Ethicon)
Active Comparator: conventional techniques of haemostasis
clips, ligatures, and bipolar coagulation
Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
bipolar, monopolar or clip coagulation techniques
Other Names:
  • Bipolar Electrosurgical instruments (Medtronic)
  • SLS- Clips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
Time Frame: Day 2
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medico-economic evaluation
Time Frame: Day 0 (Procedure)
Operating time
Day 0 (Procedure)
Medico-economic evaluation
Time Frame: Day 0 (procedure)
Cost of the two techniques by microcosting
Day 0 (procedure)
Medico-economic evaluation
Time Frame: Month 6
Total cost at month 6
Month 6
Medico-economic evaluation
Time Frame: From Day 0 until Month 6
Incremental cost effectiveness ratio
From Day 0 until Month 6
Operative morbidity
Time Frame: Month 6
Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L
Month 6
Operative morbidity
Time Frame: Until Month 6
Recurrent disease
Until Month 6
Operative morbidity
Time Frame: Day 0 to Day 2
Hemorrhagic disease
Day 0 to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Eric Mirallié, Professor, CHU Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC11_0148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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