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

NCT ID: NCT01354639

Last Updated: 2014-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Papillary Thyroid Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Group 2

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 19879615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19632588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19263137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20490558 (View on PubMed)

Other Identifiers

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4-2011-0082

Identifier Type: -

Identifier Source: org_study_id

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