Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01354639
First received: May 13, 2011
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The robotic thyroidectomy (RT) has excellent cosmetic and several functional results. But there were no definite evidence of oncological safety of robotic thyroidectomy yet. To assure the surgical completeness of robotic thyroidectomy, the investigators compared robotic thyroidectomy and conventional open thyroidectomy (OT) by means of the postoperative radioactive iodine (RAI) uptake of possible remnant thyroid tissue and stimulated TG level.


Condition
Papillary Thyroid Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • surgical completeness of conventional open thyroidectomy and robotic thyroidectomy [ Time Frame: 12 months after low dose RAI albation therapy ] [ Designated as safety issue: No ]
    check remnant thyroid uptake at Diagnostic RAI scan and stimulated serum thyroglobulin level


Enrollment: 150
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Group 1 : conventional open thyroidectomy group (papillary thyroid carcinoma patient who underwent conventional open bilateral total thyroidectomy procedure and postoperative low dose RAI therapy)
Group 2
Group 2 : robotic thyroidectomy group (papillary thyroid carcinoma patient who underwent robotic bilateral total thyroidectomy procedure and postoperative low dose RAI therapy)

  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

papillary thyroid carcinoma patient who underwent conventional open or robotic bilateral total thyroidectomy procedure and postoperative low dose RAI therapy

Criteria

Inclusion Criteria:

  • age ≥ 20years
  • papillary thyroid carcinoma patients who underwent conventional open or robotic bilateral total thyroidectomy at YUHS(Yonsei University Health System)
  • patient who underwent postoperative low doe (30mCI) RAI ablation therapy at YUHS

Exclusion Criteria:

  • pregnant, lactating women
  • patient who underwent postoperative low dose RAI at another hospital
  • patient with distant metastasis
  • patient who underwent combined operation with bilateral total thyroidectomy (ex) Modified radical neck dissection, selective neck node excision d/t lateral neck node metastasis
  • patient who underwent High dose (more than 30 mCI) RAI therapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01354639

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01354639     History of Changes
Other Study ID Numbers: 4-2011-0082
Study First Received: May 13, 2011
Last Updated: February 4, 2014
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 July 23, 2014