Clinical trial · Interventional
The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection
The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
NCT01488682CI-TRIAL-00005894unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neck dissection with conventional hand-tie ligation | Procedure | — | UNRESOLVED |
| Neck dissection with Harmonic scalpel | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Harmonic scalpel
- description
- Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation
- interventionNames
- Procedure: Neck dissection with Harmonic scalpel
- type
- ACTIVE_COMPARATOR
- label
- conventional hand tie ligation
- description
- electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels.
- interventionNames
- Procedure: neck dissection with conventional hand-tie ligation
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * preoperative diagnosis of head and neck squamous cell carcinoma * surgery as initial treatment Exclusion Criteria: * cases in which the ND specimen could not be separated from the primary tumor * past history of neck surgery
References
Publications (26)
- BACKGROUNDMcCarus SD. Physiologic mechanism of the ultrasonically activated scalpel. J Am Assoc Gynecol Laparosc. 1996 Aug;3(4):601-8. doi: 10.1016/s1074-3804(05)80174-4. PMID 9050696
- RESULTJemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. PMID 21296855
- RESULTBuSaba NY, Schaumberg DA. Predictors of prolonged length of stay after major elective head and neck surgery. Laryngoscope. 2007 Oct;117(10):1756-63. doi: 10.1097/MLG.0b013e3180de4d85. PMID 17690609
- RESULTPatel RS, McCluskey SA, Goldstein DP, Minkovich L, Irish JC, Brown DH, Gullane PJ, Lipa JE, Gilbert RW. Clinicopathologic and therapeutic risk factors for perioperative complications and prolonged hospital stay in free flap reconstruction of the head and neck. Head Neck. 2010 Oct;32(10):1345-53. doi: 10.1002/hed.21331. PMID 20091687
- RESULTSmith TL, Smith JM. Electrosurgery in otolaryngology-head and neck surgery: principles, advances, and complications. Laryngoscope. 2001 May;111(5):769-80. doi: 10.1097/00005537-200105000-00004. PMID 11359154
- RESULTRoth JH, Urbaniak JR, Boswick JM. Comparison of suture ligation, bipolar cauterization, and hemoclip ligation in the management of small branching vessels in a rat model. J Reconstr Microsurg. 1984 Jul;1(1):7-9. doi: 10.1055/s-2007-1007047. PMID 6544345
- RESULTEllman BR. New instrument for rapid hemostasis and division of small vessels. Am J Surg. 1982 Jun;143(6):772-3. doi: 10.1016/0002-9610(82)90058-7. PMID 7091517
- RESULTAmaral JF. Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel. Surg Laparosc Endosc. 1995 Aug;5(4):255-62.