Clinical trial NCT01354639: Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy
Official title: Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillary Thyroid Carcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: papillary thyroid carcinoma patient who underwent conventional open or robotic bilateral total thyroidectomy procedure and postoperative low dose RAI therapy

Brief summary: The robotic thyroidectomy (RT) has excellent cosmetic and several functional results. But there were no definite evidence of oncological safety of robotic thyroidectomy yet. To assure the surgical completeness of robotic thyroidectomy, the investigators compared robotic thyroidectomy and conventional open thyroidectomy (OT) by means of the postoperative radioactive iodine (RAI) uptake of possible remnant thyroid tissue and stimulated TG level.


Eligibility criteria: Inclusion Criteria:

* age ≥ 20years
* papillary thyroid carcinoma patients who underwent conventional open or robotic bilateral total thyroidectomy at YUHS(Yonsei University Health System)
* patient who underwent postoperative low doe (30mCI) RAI ablation therapy at YUHS

Exclusion Criteria:

* pregnant, lactating women
* patient who underwent postoperative low dose RAI at another hospital
* patient with distant metastasis
* patient who underwent combined operation with bilateral total thyroidectomy (ex) Modified radical neck dissection, selective neck node excision d/t lateral neck node metastasis
* patient who underwent High dose (more than 30 mCI) RAI therapy

Primary outcomes:
measure: surgical completeness of conventional open thyroidectomy and robotic thyroidectomy
timeFrame: 12 months after low dose RAI albation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kang SW, Lee SC, Lee SH, Lee KY, Jeong JJ, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Robotic thyroid surgery using a gasless, transaxillary approach and the da Vinci S system: the operative outcomes of 338 consecutive patients. Surgery. 2009 Dec;146(6):1048-55. doi: 10.1016/j.surg.2009.09.007. Epub 2009 Oct 30.
citation: Kang SW, Jeong JJ, Nam KH, Chang HS, Chung WY, Park CS. Robot-assisted endoscopic thyroidectomy for thyroid malignancies using a gasless transaxillary approach. J Am Coll Surg. 2009 Aug;209(2):e1-7. doi: 10.1016/j.jamcollsurg.2009.05.003. Epub 2009 Jun 12. No abstract available.
citation: Kang SW, Jeong JJ, Yun JS, Sung TY, Lee SC, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Robot-assisted endoscopic surgery for thyroid cancer: experience with the first 100 patients. Surg Endosc. 2009 Nov;23(11):2399-406. doi: 10.1007/s00464-009-0366-x. Epub 2009 Mar 5.
citation: Lee J, Nah KY, Kim RM, Ahn YH, Soh EY, Chung WY. Differences in postoperative outcomes, function, and cosmesis: open versus robotic thyroidectomy. Surg Endosc. 2010 Dec;24(12):3186-94. doi: 10.1007/s00464-010-1113-z. Epub 2010 May 19.