Thyroid DiseasesNCT01765686
Comparing Harmonic Ultrasonic Scalpel to Small Jaw Bipolar Device in Thyroid Surgery
A study testing Harmonic Scalpel (Ethicon Endo-Surgery, USA) and Ligasure Small Jaw (Covidien, USA) in people with Thyroid Diseases, run by National Cancer Centre, Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- Harmonic Scalpel (Ethicon Endo-Surgery, USA) and Ligasure Small Jaw (Covidien, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSingapore
- Study dates
- Dec 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
National Cancer Centre Singapore
Singapore, 169610
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Diseases
- Being tested
- Harmonic Scalpel (Ethicon Endo-Surgery, USA), Ligasure Small Jaw (Covidien, USA)
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic Scalpel (Ethicon Endo-Surgery, USA)Device
Ligasure Small Jaw (Covidien, USA)Device
| Study group | Role | What they receive |
|---|---|---|
| Harmonic | Active comparator | Harmonic scalpel uses ultrasound technology to coagulate and to cut tissues. Receives: Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA) |
| Small Jaw | Active comparator | Small Jaw device uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissues. Receives: Device: Ligasure Small Jaw (Covidien, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Surgery
Kife to skin time to closure time.
Measured: 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
Measured: Day 1 and on day of drain removal.
Secondary outcomes (4)
Post op complications
Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gopal Iyer, Consultant, Principal investigator, National Cancer Centre, SingaporeJeremy Ng, Consultant, Principal investigator, Singapore General HospitalKhoon Hiang Tan, Senior Consultant, Principal investigator, National Cancer Centre, SingaporeChye Ngian Tan, Consultant, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765686
- Sponsor's protocol ID
- NCCS ED 2011739D
- Status last verified
- May 2017
- First submitted
- 13 Dec 2012
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18831673Harold 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.
PubMed 12799888Rahbari 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.
PubMed 21072688Lee 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.
PubMed 31512024
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Utility of an Ultrasonic Coagulating Device (UCSD) With Electrothermal Bipolar Vessel Sealer (EBVS) in Thyroid Surgery.
- ClinicalTrials.gov ID
- NCT01765686
- Acronym / sponsor ID
- NCCS ED 2011739D
- Conditions
- Thyroid Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonic | Active comparator | Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)Harmonic scalpel uses ultrasound technology to coagulate and to cut tissues. |
| Small Jaw | Active comparator | Device: Ligasure Small Jaw (Covidien, USA)Small Jaw device uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the sealed tissues. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonic Scalpel (Ethicon Endo-Surgery, USA) | Device | Harmonic |
| Ligasure Small Jaw (Covidien, USA) | Device | Small Jaw |
Primary outcome
Duration of Surgery
Time frame: Day 1: Day of Surgery
Kife to skin time to closure time.
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
4 secondary outcomes
Post op complications
Time frame: Day 2
Ease of use
Time frame: Day 1
Vocal chords on nasal scope inspection
Time frame: Day 15 and up to 3-months post-op
Ease of use
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Background: PubMed 18831673Lamberton 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.
- Background: PubMed 12799888Harold 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.
- Background: PubMed 21072688Rahbari 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.
- Derived from this study: PubMed 31512024Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopal Iyer, Consultant principal investigator
National Cancer Centre, Singapore
Jeremy Ng, Consultant principal investigator
Singapore General Hospital
Khoon Hiang Tan, Senior Consultant principal investigator
National Cancer Centre, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harmonic Scalpel (Ethicon Endo-Surgery, USA) and Ligasure Small Jaw (Covidien, USA) in people with Thyroid Diseases, run by National Cancer Centre, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Surgery (time frame: Day 1: Day of Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765686, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.