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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01354639
Collaborator
(none)
150
Enrollment
1
Location
6
Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy
    Study Start Date :
    Apr 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Oct 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. surgical completeness of conventional open thyroidectomy and robotic thyroidectomy [12 months after low dose RAI albation therapy]

      check remnant thyroid uptake at Diagnostic RAI scan and stimulated serum thyroglobulin level

    Eligibility Criteria

    Criteria

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

    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:
    NCT01354639
    Other Study ID Numbers:
    • 4-2011-0082
    First Posted:
    May 17, 2011
    Last Update Posted:
    Feb 5, 2014
    Last Verified:
    Feb 1, 2014
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Thyroid Cancer, Papillary

    Study Results

    No Results Posted as of Feb 5, 2014