Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Thyroid Tumor

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Day 2

Safety Issue:

No

Principal Investigator

Eric Mirallié, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

RC11_0148

NCT ID:

NCT01551914

Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Thyroid Tumor
  • Ultrasonic scissors
  • thyroidectomy
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location