CompletedNCT01354639Updated Feb 5, 2014

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

An observational study in Papillary Thyroid Carcinoma, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Yonsei University · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 150
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Papillary Thyroid Carcinoma

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In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's enrollment of 150 is below the median of 172 across 261 observational studies indexed under Thyroid Neoplasms.

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Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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

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

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
Enrollment: 150 participants (actual)

Groups and cohorts

Group 1
Group 1 : conventional open thyroidectomy group (papillary thyroid carcinoma patient who underwent conventional open bilateral total thyroidectomy procedure and postoperative low dose RAI therapy)
Group 2
Group 2 : robotic thyroidectomy group (papillary thyroid carcinoma patient who underwent robotic bilateral total thyroidectomy procedure and postoperative low dose RAI therapy)

What researchers measure

Primary outcomes

surgical completeness of conventional open thyroidectomy and robotic thyroidectomy
check remnant thyroid uptake at Diagnostic RAI scan and stimulated serum thyroglobulin level
Time frame: 12 months after low dose RAI albation therapy

Study locations

1 site

Severance Hospital
Seoul, 120-752, Korea, Republic of

References and documents

Publications

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. PubMed 19879615 ↗
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. PubMed 19632588 ↗
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. PubMed 19263137 ↗
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. PubMed 20490558 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01354639
Lead sponsor: Yonsei University
Responsible party: Sponsor
First posted: May 17, 2011
Start date: Apr 2011
Primary completion: Oct 2011
Completion: Oct 2011
Last update: Feb 5, 2014

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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