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The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACEā¢, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Preciseā¢, Covidien) in surgery for thyroid cancer.
Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic coagulation device | Other | Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACEĀ® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy |
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| Bipolar Energy Sealing System | Other | Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACEĀ® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic coagulation device (Harmonic ACEĀ® scalpel) | Device | Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACEĀ® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ja Seong Bae, MD,phD | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seocho-gu | Seoul | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| bipolar energy sealing system (LigaSure Precise) | Device | Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACEĀ® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy |
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| 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 |
| Overall Survival (OS) | from date of surgery until date of death from any cause, accessed up to 60 months |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |