Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System
UCBEST
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
1 other identifier
interventional
304
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedDecember 5, 2012
December 1, 2012
1.4 years
September 2, 2011
December 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
operation time
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 Outcomes (6)
postoperative complications
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
estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
admission time
documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
Cost
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)
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
- +1 more secondary outcomes
Study Arms (2)
Ultrasonic coagulation device
OTHERComparison 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
Bipolar Energy Sealing System
OTHERComparison 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy
- patients who are agree with the study enrollment
You may not qualify if:
- an age under 20 or over 80 years
- severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems)
- a lack of consent to participate in the study
- the inability to include a patient in clinical trials according to the regulations or laws in Korea
- the inability to complete regular follow-up visits (e.g., immigration)
- the use of modified radical neck dissection due to lateral neck node metastasis
- prior thyroid surgery or cervical irradiation
- active enrollment in another clinical trial
- 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)
- the desire to undergo endoscopic or robot-assisted thyroidectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul St. Mary's Hospital
Seocho-gu, Seoul, 137-701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ja Seong Bae, MD,phD
Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Breast and Endocrine Surgery, Department of Surgery, The Catholic University of Korea College of Medicine
Study Record Dates
First Submitted
September 2, 2011
First Posted
March 28, 2012
Study Start
August 1, 2011
Primary Completion
January 1, 2013
Study Completion
August 1, 2017
Last Updated
December 5, 2012
Record last verified: 2012-12