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Secured Thyroidectomy With Intraoperative Methylene Blue Using (bluethyroid)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by SB Istanbul Education and Research Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01347606
First Posted: May 4, 2011
Last Update Posted: May 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bezmialem Vakif University
Information provided by:
SB Istanbul Education and Research Hospital
  Purpose
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
Thyroid

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Randomized Technical Study

Resource links provided by NLM:


Further study details as provided by SB Istanbul Education and Research Hospital:

Biospecimen Retention:   Samples Without DNA
thyroid tissue

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
thyroidectomy indicated patients
Criteria

Inclusion Criteria:

  • Thyroidectomy indicated patients

Exclusion Criteria:

  • Recurrent disease
  • Additional disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347606


Locations
Turkey
Bezmialem Vakif University Recruiting
Istanbul, Turkey
Contact: adnan yuksel, Prof    +902124531700    ayuksel@bezmialem.edu.tr   
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Bezmialem Vakif University
Investigators
Principal Investigator: erhan aysan, Assoc. Prof. Bezmialem Vakif University
  More Information

Responsible Party: erhan aysan, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01347606     History of Changes
Other Study ID Numbers: 4-Aysan
First Submitted: May 3, 2011
First Posted: May 4, 2011
Last Update Posted: May 4, 2011
Last Verified: January 2010

Keywords provided by SB Istanbul Education and Research Hospital:
thyroid
secure
surgery
methylene
blue