Clinical trial · Interventional
Total Thyroidectomy With Harmonic Scalpel®
Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial
- 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)
Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures. Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Goiter | — | UNRESOLVED | — |
| Thyroid Neoplasm | Thyroid Gland Neoplasm | ALIAS | 0.90 |
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Harmonic Scalpel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Postoperative complications
Secondary outcomes (5)
- measure
- Operative time
- measure
- Drainage volume
- measure
- Postoperative pain
- measure
- Length of stay
- measure
- Direct Costs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult (\>18 y/o) * Benign or malignant thyroid disease * Proposal of total thyroidectomy * Normal thyroid function Exclusion Criteria: * Giant goiter * Hyperthyroidism * Non differentiated thyroid carcinoma * Locally invasive tumors * Neck dissection as a part of procedure * Previous surgery, radiotherapy or I131 therapy on neck * Video-assisted or endoscopic thyroidectomy * Severe comorbidities * Coagulation disorders
References
Publications (0)
Data not yet available