Comparing Harmonic Ultrasonic Scalpel to Small Jaw Bipolar Device in Thyroid Surgery

National Cancer Centre, Singapore

Status: Completed

Conditions: Thyroid Diseases

Treatments: Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA); Device: Ligasure Small Jaw (Covidien, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01765686

NCCS ED 2011739D

Details and patient eligibility

About

Energy devices are used routinely during thyroid surgery to aid surgical dissection and to stop bleeding. The newer generation energy devices have several advantages over older machines. The two most commonly used newer generation energy devices are the Harmonic scalpel and the Small Jaw bipolar device. Currently there has been no randomized controlled trial that compares both devices side to side. We aim to compare the effectiveness of these two newer generation energy devices in thyroid surgery.

Full description

Energy devices are used routinely during thyroid surgery to aid surgical dissection and haemostasis. The newer generation energy devices have several advantages over older machines. First, the newer devices deliver more focussed thermal application and thus are less likely to cause collateral injury to surrounding healthy tissue. This is particularly relevant in thyroid surgery because the thyroid gland is in close proximity to vital nerves that control our airway and glands that regulate calcium metabolism. Secondly, the newer energy devices have multifunctional properties and are capable of sealing, blunt dissection, grasping and dividing tissue. This is advantageous in thyroid surgery as the operating field has many narrow areas within and the potential reduction in the exchange of instruments facilitates surgery.

Currently, two of these newer generation energy devices are available for use in Singapore General Hospital and National Cancer Centre Singapore. Both devices are similarly priced; one is based on an ultrasonic vibrating blade (UCSD) to cut and coagulate tissue while the other uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissue (EBVS). To date, clinical studies comparing both devices have only been done on animal models and focus on sealing times in animal blood vessels.

We aim to compare the effectiveness of these two newer generation energy devices in thyroid surgery by looking at the incidence of post surgical complications, post operative drainage as well as the ease of use as reflected in the operating time.

Enrollment: 100 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 21-75
• Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled my medication
• Undergoing thyroid surgery

Exclusion criteria

• Previous neck radiotherapy
• Previous neck surgery
• Patients with advanced disease that would require radical or modified neck dissection
• Patients with lobe larger than 10 cm or nodule larger than 8 cm which requires extensive dissection that may confound the study
• Patients with connective tissue diseases or chronic diseases on long-term medications that may interfere with wound healing such as steroids.
• Patients with bleeding diatheses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Harmonic

Active Comparator group

Description:

Harmonic scalpel uses ultrasound technology to coagulate and to cut tissues.

Treatment:

Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)

Small Jaw

Active Comparator group

Description:

Small Jaw device uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissues.

Treatment:

Device: Ligasure Small Jaw (Covidien, USA)