Clinical trial · Interventional
Comparative Analysis Between Bipolar Device and Conventional Tie & Suture Technique in Thyroidectomy
Comparative Analysis Between A Bipolar Vessel Sealing and Cutting Device and the Tie and Suture Technique in Thyroidectomy: A Two Institution Randomized Clinical 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)
Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments that use electrical powered diathermic energy to seal and transect tissue. These devices have shown high efficiency in a wide variety of open and laparoscopic general and gynecological surgical procedures. The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic cutting devices in several studies. However, the efficacy of this instrument and in particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in thyroid surgery. Our primary aim is to verify whether the EnSeal® performance is superior to the standard surgical technique for thyroidectomy in a randomized clinical trial on 2 different institutions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
| Thyroid Goiter | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bipolar vessel sealing and cutting device | Device | — | UNRESOLVED |
| Conventional thyroidectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thyroid Goiter
- description
- Benign thyroid disease with a nodule equal or lesser than 4 cm in diameter of any gender or ethnical origin. Half of these patients will undergo either bipolar or conventional thyroidectomy.
- interventionNames
- Device: Bipolar vessel sealing and cutting device
- Procedure: Conventional thyroidectomy
- type
- ACTIVE_COMPARATOR
- label
- Papillary Thyroid Cancer
- description
- Patients of any gender or ethnical origin with papillary thyroid cancer no greater than 4 cm in diameter. Half of these patients will undergo either bipolar or conventional thyroidectomy.
- interventionNames
- Device: Bipolar vessel sealing and cutting device
- Procedure: Conventional thyroidectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with thyroid diseases amenable of surgical resection 2. Benign or malign thyroid disease 3. Thyroid nodules ≤ 4cm 4. Patients with any gender or ethnical origin 5. Adults patients with 18-65 years-old 6. Postoperative follow-up of at least 2 weeks 7. Patients competent to understand and sign the informed consent Exclusion Criteria: 1. Patients with clinical or biochemical hyperthyroidism 2. Preoperative indication for lateral lymph node dissection (radical modified) 3. Presence of gross tracheal or laryngeal invasion with thyroid cancer 4. Preoperative vocal cord paralysis or laryngeal disease 5. Patients with bleeding disorders or using anticoagulants 6. Patients with advanced or undifferentiated thyroid cancer 7. Patients with secondary hyperparathyroidism or parathyroid disease 8. Patients who do not want to accept to participate in the study Elimination Criteria: 1. Intraoperative indication of lateral lymph node dissection (radical modified) 2. Intraoperative requirement of any tracheal or laryngeal resection 3. Malfunction of the devices (EnSeal or neuro-monitoring) 4. Any intraoperative conditions of the patient that require to stop or modified the surgery 5. Incomplete records, laboratories or clinical follow-up 6. Patients from vulnerable populations or non-competent to understand or sign the informed consent
References
Publications (3)
- BACKGROUNDJanssen PF, Brolmann HA, Huirne JA. Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review. Surg Endosc. 2012 Oct;26(10):2892-901. doi: 10.1007/s00464-012-2276-6. Epub 2012 Apr 27. PMID 22538684
- BACKGROUNDPerson B, Vivas DA, Ruiz D, Talcott M, Coad JE, Wexner SD. Comparison of four energy-based vascular sealing and cutting instruments: A porcine model. Surg Endosc. 2008 Feb;22(2):534-8. doi: 10.1007/s00464-007-9619-8. Epub 2007 Dec 20. PMID 18097720
- BACKGROUNDNewcomb WL, Hope WW, Schmelzer TM, Heath JJ, Norton HJ, Lincourt AE, Heniford BT, Iannitti DA. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009 Jan;23(1):90-6. doi: 10.1007/s00464-008-9932-x. Epub 2008 May 16. PMID 18483824