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Thyroid TumorPhase 3FOThyrNCT01551914

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

A Phase 3 study testing Ultrasonic Scissors (Ethicon) and Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips) in people with Thyroid Tumor, run by Nantes University Hospital at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Tumor
What is being tested?
Ultrasonic Scissors (Ethicon) and Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,350 participants
Where
1 siteFrance
Study dates
Mar 2012to Mar 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Nantes

    Nantes, Nantes, 44000

Other trials in France

About this study

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
Being tested
Ultrasonic Scissors (Ethicon), Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
Keywords
Ultrasonic scissors, thyroidectomy
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasonic Scissors (Ethicon)Device

    Also called Harmonic Focus scissors (Ethicon)

    Haemostasis using Ultrasonic scissors

  • Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)Device

    Also called Bipolar Electrosurgical instruments (Medtronic), SLS- Clips

    bipolar, monopolar or clip coagulation techniques

Study groups in NCT01551914
Study groupRoleWhat they receive
ultrasonic scissorsExperimentalNot described
Receives: Device: Ultrasonic Scissors (Ethicon)
conventional techniques of haemostasisActive comparatorclips, ligatures, and bipolar coagulation
Receives: Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)

    Measured: Day 2

Secondary outcomes (7)

  1. Medico-economic evaluation

    Operating time

    Measured: Day 0 (Procedure)

  2. Medico-economic evaluation

    Cost of the two techniques by microcosting

    Measured: Day 0 (procedure)

  3. Medico-economic evaluation

    Total cost at month 6

    Measured: Month 6

  4. Medico-economic evaluation

    Incremental cost effectiveness ratio

    Measured: From Day 0 until Month 6

  5. Operative morbidity

    Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L

    Measured: Month 6

  6. Operative morbidity

    Recurrent disease

    Measured: Until Month 6

  7. Operative morbidity

    Hemorrhagic disease

    Measured: Day 0 to Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2014 (estimated)
  4. Study completionMar 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01551914
Sponsor's protocol ID
RC11_0148
Acronym
FOThyr
Status last verified
Jun 2014
First submitted
23 Feb 2012
Last updated
1 Jul 2014
Results posted
No

Publications

  • Christou N, Blanchard C, Pattou F, Volteau C, Brunaud L, Hamy A, Dahan M, Prades JM, Landecy G, Dernis HP, Lifante JC, Sebag F, Jegoux F, Babin E, Bizon A, Caillard C, Mathonnet M, Mirallie E. Advanced age does not increase morbidity after total thyroidectomy. Result of a prospective study. Am J Surg. 2019 Apr;217(4):767-771. doi: 10.1016/j.amjsurg.2018.07.029. Epub 2018 Jul 25.

    PubMed 30055804

  • Blanchard C, Pattou F, Brunaud L, Hamy A, Dahan M, Mathonnet M, Volteau C, Caillard C, Durand-Zaleski I, Mirallie E; FOThyr Group. Randomized clinical trial of ultrasonic scissors versus conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr). BJS Open. 2017 May 9;1(1):2-10. doi: 10.1002/bjs5.2. eCollection 2017 Feb.

    PubMed 29951599

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ultrasonic Scissors (Ethicon) and Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips) in people with Thyroid Tumor, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2) (time frame: Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01551914, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.

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