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

Primary Purpose

Thyroid Tumor

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ultrasonic Scissors (Ethicon)
Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Tumor focused on measuring Ultrasonic scissors, thyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ultrasonic scissors

conventional techniques of haemostasis

Arm Description

clips, ligatures, and bipolar coagulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Medico-economic evaluation
Operating time
Medico-economic evaluation
Cost of the two techniques by microcosting
Medico-economic evaluation
Total cost at month 6
Medico-economic evaluation
Incremental cost effectiveness ratio
Operative morbidity
Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L
Operative morbidity
Recurrent disease
Operative morbidity
Hemorrhagic disease

Full Information

First Posted
February 23, 2012
Last Updated
June 30, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01551914
Brief Title
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
Acronym
FOThyr
Official Title
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Tumor
Keywords
Ultrasonic scissors, thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasonic scissors
Arm Type
Experimental
Arm Title
conventional techniques of haemostasis
Arm Type
Active Comparator
Arm Description
clips, ligatures, and bipolar coagulation
Intervention Type
Device
Intervention Name(s)
Ultrasonic Scissors (Ethicon)
Other Intervention Name(s)
Harmonic Focus scissors (Ethicon)
Intervention Description
Haemostasis using Ultrasonic scissors
Intervention Type
Device
Intervention Name(s)
Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
Other Intervention Name(s)
Bipolar Electrosurgical instruments (Medtronic), SLS- Clips
Intervention Description
bipolar, monopolar or clip coagulation techniques
Primary Outcome Measure Information:
Title
Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Medico-economic evaluation
Description
Operating time
Time Frame
Day 0 (Procedure)
Title
Medico-economic evaluation
Description
Cost of the two techniques by microcosting
Time Frame
Day 0 (procedure)
Title
Medico-economic evaluation
Description
Total cost at month 6
Time Frame
Month 6
Title
Medico-economic evaluation
Description
Incremental cost effectiveness ratio
Time Frame
From Day 0 until Month 6
Title
Operative morbidity
Description
Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L
Time Frame
Month 6
Title
Operative morbidity
Description
Recurrent disease
Time Frame
Until Month 6
Title
Operative morbidity
Description
Hemorrhagic disease
Time Frame
Day 0 to Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Mirallié, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30055804
Citation
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.
Results Reference
derived
PubMed Identifier
29951599
Citation
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.
Results Reference
derived

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

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