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

Not Applicable

Completed

• Conditions: Thyroid Diseases
• Interventions: Device: Ligasure Small Jaw (Covidien, USA); Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)

• Registration Number: NCT01765686
• Lead Sponsor: National Cancer Centre, Singapore

Brief Summary

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

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Small Jaw	Ligasure Small Jaw (Covidien, USA)	Small Jaw device uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissues.
Harmonic	Harmonic Scalpel (Ethicon Endo-Surgery, USA)	Harmonic scalpel uses ultrasound technology to coagulate and to cut tissues.

Primary Outcome Measures

Name	Time	Method
Duration of Surgery	Day 1: Day of Surgery	Kife to skin time to closure time.
Bleeding	Day 1 and on day of drain removal.	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

Secondary Outcome Measures

Name	Time	Method
Post op complications	Day 2	Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.
Vocal chords on nasal scope inspection	Day 15 and up to 3-months post-op	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.
Ease of use	Day 1	Measure interruption to device use, absolute failure that necessitates equipment changes, incomplete hemostasis requiring additional tying with silk sutures.

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore