Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

Papillary Thyroid Carcinoma Clinical Trial

Official title:

Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354639
• Other study ID #: 4-2011-0082
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: February 4, 2014
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Carcinoma
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical completeness of conventional open thyroidectomy and robotic thyroidectomy	check remnant thyroid uptake at Diagnostic RAI scan and stimulated serum thyroglobulin level	12 months after low dose RAI albation therapy	No