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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Singapore General Hospital
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
Duration of Surgery
Kife to skin time to closure time.
Time frame: Day 1: Day of Surgery
Bleeding
Measured blood loss during surgery including suction amount minus the irrigation fluid used as well as the number of gauzes. Drain amount is also recorded postoperatively
Time frame: Day 1 and on day of drain removal.
Post op complications
Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.
Time frame: Day 2
Ease of use
Surgeon's comment on ease of use, number of nerve identified, number of parathyroid gland identified, staff's inputs on ease of use.
Time frame: Day 1
Vocal chords on nasal scope inspection
Nasal scope will be done for all subjects at 2-week post operative. If normal, subject does not need to undergo the 2nd nasal scope at 3-month visit.
Time frame: Day 15 and up to 3-months post-op
Ease of use
Measure interruption to device use, absolute failure that necessitates equipment changes, incomplete hemostasis requiring additional tying with silk sutures.
Time frame: Day 1
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