Clinical trial · Interventional
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Tumor | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips) | Device | — | UNRESOLVED |
| Ultrasonic Scissors (Ethicon) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ultrasonic scissors
- interventionNames
- Device: Ultrasonic Scissors (Ethicon)
- type
- ACTIVE_COMPARATOR
- label
- conventional techniques of haemostasis
- description
- clips, ligatures, and bipolar coagulation
- interventionNames
- Device: Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)
Primary outcomes (1)
- measure
- Immediate hypoparathyroidism (serum calcium <2 mmol/L at day 2)
- timeFrame
- Day 2
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDChristou 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 30055804
- DERIVEDBlanchard 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 29951599