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
20 Years
80 Years
Both
Thyroid Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
operation time
Outcome Description:
from skin incision to skin closure
Outcome Time Frame:
from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery
Safety Issue:
No
Principal Investigator
Ja Seong Bae, MD,phD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul St. Mary's Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
KC11DISI0534
NCT ID:
NCT01565486
Start Date:
August 2011
Completion Date:
August 2017
Related Keywords:
- Thyroid Cancer
- operation time
- complication rate
- costs
- admission time
- RFS
- OS
- Thyroid Neoplasms
- Thyroid Diseases
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