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

NCT ID: NCT01565486

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Thyroid Cancer

Keywords

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operation time complication rate costs admission time RFS OS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type OTHER

Ultrasonic coagulation device (Harmonic ACE® scalpel)

Intervention Type 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

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

Group Type OTHER

bipolar energy sealing system (LigaSure Precise)

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Harmonic ACE® scalpel LigaSure Precise instrument

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ja Seong Bae, MD, phD

Division of Breast and Endocrine Surgery, Department of Surgery, The Catholic University of Korea College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ja Seong Bae, MD,phD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seocho-gu, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KC11DISI0534

Identifier Type: -

Identifier Source: org_study_id