Clinical trial NCT01565486: Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Keywords: operation time
complication rate
costs
admission time
RFS
OS
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 304
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: operation time
timeFrame: 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
timeFrame: at 3 hours, 1, 2, 3, 10 days and 1 months after surgery and 6 months and every 1 years after surgery
measure: postoperative drainage volume
timeFrame: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
measure: admission time
timeFrame: documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
measure: Cost
timeFrame: documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
measure: Relapse-free survival (RFS)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: from date of surgery until date of death from any cause, accessed up to 60 months
Other outcomes:
Locations:
city: Seocho-gu
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seoul
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Ja Seong Bae, MD,phD
role: PRINCIPAL_INVESTIGATOR
References: