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

Seoul St. Mary's Hospital304 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

304

Conditions

Thyroid Cancer

Interventions

Ultrasonic coagulation device (Harmonic ACE® scalpel)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 (LigaSure Precise)DEVICE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul St. Mary's Hospital

Seocho-gu, Seoul, South Korea

Outcomes

Primary Outcomes

operation time

from skin incision to skin closure

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.