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

December 4, 2012 updated by: Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Seocho-gu, Seoul, Korea, Republic of, 137-701
        • Seoul St. Mary'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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 Names:
  • Harmonic ACE® scalpel
Other: 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
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 Names:
  • LigaSure Precise instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
from date of surgery until date of death from any cause, accessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Principal Investigator: Ja Seong Bae, MD,phD, Seoul St. Mary'S Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC11DISI0534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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