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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01551914
First received: February 23, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Thyroid Tumor
Device: Ultrasonic Scissors (Ethicon)
Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medico-economic evaluation [ Time Frame: Day 0 (Procedure) ] [ Designated as safety issue: No ]
    Operating time

  • Medico-economic evaluation [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
    Cost of the two techniques by microcosting

  • Medico-economic evaluation [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Total cost at month 6

  • Medico-economic evaluation [ Time Frame: From Day 0 until Month 6 ] [ Designated as safety issue: No ]
    Incremental cost effectiveness ratio

  • Operative morbidity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Final hypoparathyroidism: calcium in the sixth postoperative month inferior than 2 mmol / L

  • Operative morbidity [ Time Frame: Until Month 6 ] [ Designated as safety issue: No ]
    Recurrent disease

  • Operative morbidity [ Time Frame: Day 0 to Day 2 ] [ Designated as safety issue: Yes ]
    Hemorrhagic disease


Estimated Enrollment: 1350
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ultrasonic scissors Device: Ultrasonic Scissors (Ethicon)
Haemostasis using Ultrasonic scissors
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551914

Locations
France
CHU Nantes
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Eric Mirallié, Professor CHU Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01551914     History of Changes
Other Study ID Numbers: RC11_0148
Study First Received: February 23, 2012
Last Updated: June 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Ultrasonic scissors
thyroidectomy

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014