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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01565486
First received: September 2, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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)


Condition Intervention
Thyroid Cancer
Device: Ultrasonic coagulation device (Harmonic ACE® scalpel)
Device: bipolar energy sealing system (LigaSure Precise)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    from skin incision to skin closure


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: from date of surgery until date of death from any cause, accessed up to 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: August 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01565486

Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seocho-gu, Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
Principal Investigator: Ja Seong Bae, MD,phD Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Ja Seong Bae, MD, phD, Division of Breast and Endocrine Surgery, Department of Surgery, The Catholic University of Korea College of Medicine, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01565486     History of Changes
Other Study ID Numbers: KC11DISI0534
Study First Received: September 2, 2011
Last Updated: December 4, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul St. Mary's Hospital:
operation time
complication rate
costs
admission time
RFS
OS

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on September 16, 2014