NCT01765686

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Diseases

Interventions

Type	Name	Description
DEVICE	Harmonic Scalpel (Ethicon Endo-Surgery, USA)
DEVICE	Ligasure Small Jaw (Covidien, USA)

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2013-01-10
• Last updated: 2017-05-22

Locations

2 sites across 1 country: Singapore