Clinical trial NCT01765686: Comparing Harmonic Ultrasonic Scalpel to Small Jaw Bipolar Device in Thyroid Surgery
Official title: Randomized Controlled Trial Comparing the Utility of an Ultrasonic Coagulating Device (UCSD) With Electrothermal Bipolar Vessel Sealer (EBVS) in Thyroid Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Diseases
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Surgery
timeFrame: Day 1: Day of Surgery
measure: Bleeding
timeFrame: Day 1 and on day of drain removal.
Secondary outcomes:
measure: Post op complications
timeFrame: Day 2
measure: Ease of use
timeFrame: Day 1
measure: Vocal chords on nasal scope inspection
timeFrame: Day 15 and up to 3-months post-op
measure: Ease of use
timeFrame: Day 1
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Gopal Iyer, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Jeremy Ng, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Centre, Singapore
name: Khoon Hiang Tan, Senior Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Centre, Singapore
name: Chye Ngian Tan, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Harold KL, Pollinger H, Matthews BD, Kercher KW, Sing RF, Heniford BT. Comparison of ultrasonic energy, bipolar thermal energy, and vascular clips for the hemostasis of small-, medium-, and large-sized arteries. Surg Endosc. 2003 Aug;17(8):1228-30. doi: 10.1007/s00464-002-8833-7. Epub 2003 Jun 13.
citation: Rahbari R, Mathur A, Kitano M, Guerrero M, Shen WT, Duh QY, Clark OH, Kebebew E. Prospective randomized trial of ligasure versus harmonic hemostasis technique in thyroidectomy. Ann Surg Oncol. 2011 Apr;18(4):1023-7. doi: 10.1245/s10434-010-1251-5. Epub 2010 Nov 12.
citation: Lee SH, Nguyen TK, Ong WS, Haaland B, Tay GC, Tan NC, Tan HK, Ng JCF, Iyer NG. Comparing the Utility and Surgical Outcomes of Harmonic Focus Ultrasonic Scalpel with Ligasure Small Jaw Bipolar Device in Thyroidectomies: A Prospective Randomized Controlled Trial. Ann Surg Oncol. 2019 Dec;26(13):4414-4422. doi: 10.1245/s10434-019-07806-w. Epub 2019 Sep 11.