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Completed

NCT Number: NCT01765686

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

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.

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Key information

Conditions

Thyroid Diseases Endocrine System Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Harmonic Scalpel (Ethicon Endo-Surgery, USA)

Device

Ligasure Small Jaw (Covidien, USA)

Device

Primary outcomes

  1. Duration of Surgery

    Time frame: Day 1: Day of Surgery

    Kife to skin time to closure time.

  2. Bleeding

    Time frame: 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 outcomes

  1. Post op complications

    Time frame: Day 2

    Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.

  2. Ease of use

    Time frame: Day 1

    Surgeon's comment on ease of use, number of nerve identified, number of parathyroid gland identified, staff's inputs on ease of use.

  3. Vocal chords on nasal scope inspection

    Time frame: 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.

  4. Ease of use

    Time frame: Day 1

    Measure interruption to device use, absolute failure that necessitates equipment changes, incomplete hemostasis requiring additional tying with silk sutures.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2013
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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