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.
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMay 22, 2017
May 1, 2017
3.5 years
December 13, 2012
May 19, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Post op complications
Day 2
Ease of use
Day 1
Vocal chords on nasal scope inspection
Day 15 and up to 3-months post-op
Ease of use
Day 1
Study Arms (2)
Harmonic
ACTIVE COMPARATORHarmonic scalpel uses ultrasound technology to coagulate and to cut tissues.
Small Jaw
ACTIVE COMPARATORSmall Jaw device uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissues.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Singapore General Hospital
Singapore, 169608, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
Related Publications (4)
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.
PMID: 18831673BACKGROUNDHarold 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.
PMID: 12799888BACKGROUNDRahbari 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.
PMID: 21072688BACKGROUNDLee 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.
PMID: 31512024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2012
First Posted
January 10, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
May 22, 2017
Record last verified: 2017-05