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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01311089
Collaborator
(none)
169
Enrollment
1
Location
8
Duration (Months)
21.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    169 participants
    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
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2011
    Actual Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Severance Hospital Seoul Korea, Republic of 120-752

      Sponsors and Collaborators

      • Yonsei University

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Yonsei University
      ClinicalTrials.gov Identifier:
      NCT01311089
      Other Study ID Numbers:
      • 1-2010-0055
      First Posted:
      Mar 9, 2011
      Last Update Posted:
      Jan 27, 2015
      Last Verified:
      Jan 1, 2015
      Additional relevant MeSH terms:
      Thyroid Neoplasms
      Thyroid Cancer, Papillary

      Study Results

      No Results Posted as of Jan 27, 2015