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Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System (UCBEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565486
Recruitment Status : Unknown
Verified December 2012 by Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 28, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital

Tracking Information
First Submitted Date  ICMJE September 2, 2011
First Posted Date  ICMJE March 28, 2012
Last Update Posted Date December 5, 2012
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
operation time [ Time Frame: from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery ]
from skin incision to skin closure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • postoperative complications [ Time Frame: at 3 hours, 1, 2, 3, 10 days and 1 months after surgery and 6 months and every 1 years after surgery ]
  • postoperative drainage volume [ Time Frame: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery ]
  • admission time [ Time Frame: documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery ]
  • Cost [ Time Frame: documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery ]
  • Relapse-free survival (RFS) [ Time Frame: from date of surgery until date of first documented recurrence or date of death from any cause, whichever came first, accessed up to 60 months ]
  • Overall Survival (OS) [ Time Frame: from date of surgery until date of death from any cause, accessed up to 60 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System
Official Title  ICMJE Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated With the Harmonic ACE® Scalpel and LigaSure Precise™ Instrument During Conventional Thyroidectomy: A Single-blind Prospective Randomized Controlled Trial
Brief Summary

The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer.

Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)

Detailed Description Background: Thyroid is an organ that has abundant vessels. In thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. Recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. UC and BES are now commonly used in thyroid surgery. However, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. Thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (RFS and OS) between the two surgical devices in surgery for thyroid cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Cancer
Intervention  ICMJE
  • Device: Ultrasonic coagulation device (Harmonic ACE® scalpel)
    Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
    Other Name: Harmonic ACE® scalpel
  • Device: bipolar energy sealing system (LigaSure Precise)
    Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
    Other Name: LigaSure Precise instrument
Study Arms  ICMJE
  • Ultrasonic coagulation device
    Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
    Intervention: Device: Ultrasonic coagulation device (Harmonic ACE® scalpel)
  • Bipolar Energy Sealing System
    Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
    Intervention: Device: bipolar energy sealing system (LigaSure Precise)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 26, 2012)
304
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy
  2. patients who are agree with the study enrollment

Exclusion Criteria:

  1. an age under 20 or over 80 years
  2. severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems)
  3. a lack of consent to participate in the study
  4. the inability to include a patient in clinical trials according to the regulations or laws in Korea
  5. the inability to complete regular follow-up visits (e.g., immigration)
  6. the use of modified radical neck dissection due to lateral neck node metastasis
  7. prior thyroid surgery or cervical irradiation
  8. active enrollment in another clinical trial
  9. the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time)
  10. the desire to undergo endoscopic or robot-assisted thyroidectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565486
Other Study ID Numbers  ICMJE KC11DISI0534
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Seoul St. Mary's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ja Seong Bae, MD,phD Seoul St. Mary's Hospital
PRS Account Seoul St. Mary's Hospital
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP