NCT01551914

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,350

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

2.6 years

First QC Date

February 23, 2012

Last Update Submit

June 30, 2014

Conditions

Thyroid Tumor

Keywords

Ultrasonic scissorsthyroidectomy

Outcome Measures

Primary Outcomes (1)

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

    Day 2

Secondary Outcomes (7)

  • Medico-economic evaluation

    Day 0 (Procedure)

  • Medico-economic evaluation

    Day 0 (procedure)

  • Medico-economic evaluation

    Month 6

  • Medico-economic evaluation

    From Day 0 until Month 6

  • Operative morbidity

    Month 6

  • +2 more secondary outcomes

Study Arms (2)

ultrasonic scissors

EXPERIMENTAL
Device: Ultrasonic Scissors (Ethicon)

conventional techniques of haemostasis

ACTIVE COMPARATOR

clips, ligatures, and bipolar coagulation

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

Interventions

Ultrasonic Scissors (Ethicon)DEVICE

Haemostasis using Ultrasonic scissors

Also known as: Harmonic Focus scissors (Ethicon)
ultrasonic scissors
Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)DEVICE

bipolar, monopolar or clip coagulation techniques

Also known as: Bipolar Electrosurgical instruments (Medtronic), SLS- Clips
conventional techniques of haemostasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nantes

Nantes, Nantes, 44000, France

Location

Related Publications (2)

  • 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.

    PMID: 30055804DERIVED

  • 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.

    PMID: 29951599DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Eric Mirallié, Professor

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

FR(1)