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bluethyroid: Secured Thyroidectomy With Intraoperative Methylene Blue Using

Sponsor
SB Istanbul Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01347606
Collaborator
Bezmialem Vakif University (Other)
20
Enrollment
1
Location
17.9
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using. In the operation when thyroid lobes manipulated to medially, methylene blue will be sprayed to this area. Dying patternes of tissues (thyroid tissue, oparathyroid tissues, arteries, venules and neural structures) will ensure to identification the tissues.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Time Perspective:
    Prospective
    Official Title:
    Prospective Randomized Technical Study
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2011
    Anticipated Study Completion Date :
    Jul 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Thyroidectomy indicated patients
      Exclusion Criteria:

      • Recurrent disease

      • Additional disease

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Bezmialem Vakif University Istanbul Turkey

      Sponsors and Collaborators

      • SB Istanbul Education and Research Hospital
      • Bezmialem Vakif University

      Investigators

      • Principal Investigator: erhan aysan, Assoc. Prof., Bezmialem Vakif University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01347606
      Other Study ID Numbers:
      • 4-Aysan
      First Posted:
      May 4, 2011
      Last Update Posted:
      May 4, 2011
      Last Verified:
      Jan 1, 2010
      Keywords provided by , ,
      thyroid
      secure
      surgery
      methylene
      blue
      Additional relevant MeSH terms:
      Thyroid Diseases

      Study Results

      No Results Posted as of May 4, 2011