A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy

NCT ID: NCT01311089

Last Updated: 2015-01-27

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

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction.

Detailed Description

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Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. In this study, we designed a prospective study comparing the cosmetic satisfaction and the postoperative body image change which associated with patient self-esteem between robotic thyroidectomy and conventional open thyroidectomy group.

Conditions

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Papillary Thyroid Carcinoma

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic thyroidectomy group

Robotic thyroidectomy group is the patient group who underwent robot-assisted endoscopic thyroid surgery using a gasless, trans-axillary approach.

No interventions assigned to this group

conventional open thyroidectomy group

Conventional open thyroidectomy group is th patient group who underwent thyroid surgery via neck incision.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with papillary thyroid carcinoma who underwent thyroidectomy
* Age was over 20 years old

Exclusion Criteria

* Keloid
* Previous neck or anterior chest operation history
* The patients who underwent combined radical neck dissection
* The patient with postoperative wound problem
* The patient with underlying systemic disease which can make influences on the wound healing process
* The patient who can not read and understand the questionnaire
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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Tan CT, Cheah WK, Delbridge L. "Scarless" (in the neck) endoscopic thyroidectomy (SET): an evidence-based review of published techniques. World J Surg. 2008 Jul;32(7):1349-57. doi: 10.1007/s00268-008-9555-3.

Reference Type BACKGROUND
PMID: 18360737 (View on PubMed)

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)

Jeong JJ, Kang SW, Yun JS, Sung TY, Lee SC, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Comparative study of endoscopic thyroidectomy versus conventional open thyroidectomy in papillary thyroid microcarcinoma (PTMC) patients. J Surg Oncol. 2009 Nov 1;100(6):477-80. doi: 10.1002/jso.21367.

Reference Type BACKGROUND
PMID: 19653245 (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)

Chung YS, Choe JH, Kang KH, Kim SW, Chung KW, Park KS, Han W, Noh DY, Oh SK, Youn YK. Endoscopic thyroidectomy for thyroid malignancies: comparison with conventional open thyroidectomy. World J Surg. 2007 Dec;31(12):2302-6; discussion 2307-8. doi: 10.1007/s00268-007-9117-0.

Reference Type BACKGROUND
PMID: 17566819 (View on PubMed)

Yoon JH, Park CH, Chung WY. Gasless endoscopic thyroidectomy via an axillary approach: experience of 30 cases. Surg Laparosc Endosc Percutan Tech. 2006 Aug;16(4):226-31. doi: 10.1097/00129689-200608000-00006.

Reference Type BACKGROUND
PMID: 16921301 (View on PubMed)

Inukai M, Usui Y. Clinical evaluation of gasless endoscopic thyroid surgery. Surg Today. 2005;35(3):199-204. doi: 10.1007/s00595-004-2929-8.

Reference Type BACKGROUND
PMID: 15772789 (View on PubMed)

Ohgami M, Ishii S, Arisawa Y, Ohmori T, Noga K, Furukawa T, Kitajima M. Scarless endoscopic thyroidectomy: breast approach for better cosmesis. Surg Laparosc Endosc Percutan Tech. 2000 Feb;10(1):1-4.

Reference Type BACKGROUND
PMID: 10872517 (View on PubMed)

Ikeda Y, Takami H, Sasaki Y, Takayama J, Niimi M, Kan S. Comparative study of thyroidectomies. Endoscopic surgery versus conventional open surgery. Surg Endosc. 2002 Dec;16(12):1741-5. doi: 10.1007/s00464-002-8830-x. Epub 2002 Jul 29.

Reference Type BACKGROUND
PMID: 12140635 (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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1-2010-0055

Identifier Type: -

Identifier Source: org_study_id

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