Comparing Harmonic Ultrasonic Scalpel to Small Jaw Bipolar Device in Thyroid Surgery
Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)
Device: Ligasure Small Jaw (Covidien, USA)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial Comparing the Utility of an Ultrasonic Coagulating Device (UCSD) With Electrothermal Bipolar Vessel Sealer (EBVS) in Thyroid Surgery.|
- Duration of Surgery [ Time Frame: Day 1: Day of Surgery ] [ Designated as safety issue: No ]Kife to skin time to closure time.
- Bleeding [ Time Frame: Day 1 and on day of drain removal. ] [ Designated as safety issue: Yes ]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
- Post op complications [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.
- Ease of use [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Surgeon's comment on ease of use, number of nerve identified, number of parathyroid gland identified, staff's inputs on ease of use.
- Vocal chords on nasal scope inspection [ Time Frame: Day 15 and up to 3-months post-op ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Measure interruption to device use, absolute failure that necessitates equipment changes, incomplete hemostasis requiring additional tying with silk sutures.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Harmonic
Harmonic scalpel uses ultrasound technology to coagulate and to cut tissues.
|Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)|
Active Comparator: Small Jaw
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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765686
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|National Cancer Centre Singapore|
|Singapore, Singapore, 169610|
|Principal Investigator:||Gopal Iyer, Consultant||National Cancer Centre, Singapore|
|Principal Investigator:||Jeremy Ng, Consultant||Singapore General Hospital|
|Principal Investigator:||Khoon Hiang Tan, Senior Consultant||National Cancer Centre, Singapore|
|Principal Investigator:||Chye Ngian Tan, Consultant||National Cancer Centre, Singapore|