Overview

This trial is active, not recruiting.

Condition thyroid cancer
Treatments ultrasonic coagulation device (harmonic ace® scalpel), bipolar energy sealing system (ligasure precise)
Sponsor Seoul St. Mary's Hospital
Start date August 2011
End date January 2013
Trial size 304 participants
Trial identifier NCT01565486, KC11DISI0534

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Other)
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
ultrasonic coagulation device (harmonic ace® scalpel) 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)
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 (ligasure precise) LigaSure Precise instrument
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

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
Principal investigator Ja Seong Bae, MD,phD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Seoul St. Mary's Hospital.