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Randomized Controlled Trial Comparing the Utility of an Ultrasonic Coagulating Device (UCSD) With Electrothermal Bipolar Vessel Sealer (EBVS) in Thyroid Surgery.

21 Years
75 Years
Open (Enrolling)
Thyroid Surgery

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Trial Information

Randomized Controlled Trial Comparing the Utility of an Ultrasonic Coagulating Device (UCSD) With Electrothermal Bipolar Vessel Sealer (EBVS) in Thyroid Surgery.

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Duration of Surgery

Outcome Description:

Kife to skin time to closure time.

Outcome Time Frame:

Day 1: Day of Surgery

Safety Issue:


Principal Investigator

Gopal Iyer, Consultant

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Centre, Singapore


Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Study ID:

NCCS ED 2011739D



Start Date:

December 2012

Completion Date:

March 2014

Related Keywords:

  • Thyroid Surgery
  • Thyroid Diseases