The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

Yonsei University

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Procedure: neck dissection with conventional hand-tie ligation; Procedure: Neck dissection with Harmonic scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT01488682

1-2011-0014

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Harmonic scalpel

Experimental group

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

Treatment:

Procedure: Neck dissection with Harmonic scalpel

conventional hand tie ligation

Active Comparator group

Description:

electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels.

Treatment:

Procedure: neck dissection with conventional hand-tie ligation