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.

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Diseases
• Intervention / Treatment: Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA); Device: Ligasure Small Jaw (Covidien, USA)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Surgery	Kife to skin time to closure time.	Day 1: Day of Surgery
Bleeding	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	Day 1 and on day of drain removal.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post op complications	Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.	Day 2
Ease of use	Surgeon's comment on ease of use, number of nerve identified, number of parathyroid gland identified, staff's inputs on ease of use.	Day 1
Vocal chords on nasal scope inspection	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.	Day 15 and up to 3-months post-op
Ease of use	Measure interruption to device use, absolute failure that necessitates equipment changes, incomplete hemostasis requiring additional tying with silk sutures.	Day 1

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Investigators: 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

Publications and helpful links

General Publications

• Lamberton GR, Hsi RS, Jin DH, Lindler TU, Jellison FC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008 Oct;22(10):2307-12. doi: 10.1089/end.2008.9715.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: NCCS ED 2011739D