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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01311089
First received: March 8, 2011
Last updated: January 31, 2012
Last verified: January 2012

March 8, 2011
January 31, 2012
January 2011
August 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01311089 on ClinicalTrials.gov Archive Site
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A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy
A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy : Postoperative Body Image Change and Cosmetic Satisfaction

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

120 patients with papillary thyroid carcinoma who underwent thyroidectomy at Yonsei University Health System were enrolled. 60patients were conventional open thyroidectomy group and 60 patients were robotic thyroidectomy group. All of these patients was over 20 years old.

Papillary Thyroid Carcinoma
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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.
  • conventional open thyroidectomy group
    Conventional open thyroidectomy group is th patient group who underwent thyroid surgery via neck incision.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Korea, Republic of
 
NCT01311089
1-2010-0055
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP