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

Papillary Thyroid Carcinoma Clinical Trial

Official title:

A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy : Postoperative Body Image Change and Cosmetic Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311089
• Other study ID #: 1-2010-0055
• Status: Completed
• Phase: N/A
• First received: March 8, 2011
• Last updated: January 26, 2015
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2015
• 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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 (10)

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. — View Citation

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. Epub 2002 Jul 29. — View Citation

Inukai M, Usui Y. Clinical evaluation of gasless endoscopic thyroid surgery. Surg Today. 2005;35(3):199-204. — View Citation

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. — View 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. — 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

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. — View Citation

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. Review. — View Citation

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. — View Citation