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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Cancer Centre, Singapore
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT01765686
First received: December 13, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Thyroid Surgery
Device: Harmonic Scalpel (Ethicon Endo-Surgery, USA)
Device: Ligasure Small Jaw (Covidien, USA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Utility of an Ultrasonic Coagulating Device (UCSD) With Electrothermal Bipolar Vessel Sealer (EBVS) in Thyroid Surgery.

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • Duration of Surgery [ Time Frame: Day 1: Day of Surgery ] [ Designated as safety issue: No ]
    Kife to skin time to closure time.

  • Bleeding [ Time Frame: Day 1 and on day of drain removal. ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Post op complications [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
    Voice hoarseness, adverse events, stridor, difficulty breathing and other common complications of thyroid surgery are recorded.

  • Ease of use [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Surgeon's comment on ease of use, number of nerve identified, number of parathyroid gland identified, staff's inputs on ease of use.

  • Vocal chords on nasal scope inspection [ Time Frame: Day 15 and up to 3-months post-op ] [ Designated as safety issue: Yes ]
    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.

  • Ease of use [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Measure interruption to device use, absolute failure that necessitates equipment changes, incomplete hemostasis requiring additional tying with silk sutures.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765686

Contacts
Contact: Khanh Thien Nguyen, B.S +65 8518 0626 nguyenthienkhanh@nus.edu.sg

Locations
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Contact: Khanh T Nguyen, BS    6585180626    nguyenthienkhanh@nus.edu.sg   
Contact    6581257251      
Principal Investigator: Gopal Iyer, MBBS, PhD         
Sub-Investigator: Chye N Tan, MBBS         
Sub-Investigator: Khoon H Tan, MBBS, PhD         
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Khanh T Nguyen, BS    6585180626    nguyenthienkhanh@nus.edu.sg   
Principal Investigator: Jeremy Ng, MBBS         
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT01765686     History of Changes
Other Study ID Numbers: NCCS ED 2011739D
Study First Received: December 13, 2012
Last Updated: November 18, 2013
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Singapore: Institutional Review Board
Singapore: Ministry of Health
Singapore: Singapore Clinical Research Institute

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on November 20, 2014