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
  Purpose

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.


Condition
Papillary Thyroid Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy : Postoperative Body Image Change and Cosmetic Satisfaction

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311089

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woong-Youn Chung, MD, Ph.D    82-2-228-2100    woungyounc@yuhs.ac   
Contact: So-Hee Lee, MD, Ph.D    82-2-2228-2100    leesohee@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01311089     History of Changes
Other Study ID Numbers: 1-2010-0055
Study First Received: March 8, 2011
Last Updated: January 31, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on September 14, 2014