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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Thyroid Diseases

Intervention / Treatment
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* Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)
* Device: Ligasure Small Jaw (Covidien, USA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Harmonic<br>Harmonic scalpel uses ultrasound technology to coagulate and to cut tissues. | Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)<br> <br> |
| Active Comparator: Small Jaw<br>Small Jaw device uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissues. | Device: Ligasure Small Jaw (Covidien, USA)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery | Kife to skin time to closure time. | 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 | Day 1 and on day of drain removal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post op complications | Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded. | 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. | 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. | 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. | Day 1 |