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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001100
Receipt No. R000001333
Scientific Title Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma
Date of disclosure of the study information 2008/04/01
Last modified on 2012/03/28

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Basic information
Public title Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma
Acronym Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma
Scientific Title Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma
Scientific Title:Acronym Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma
Region
Japan

Condition
Condition papillary thyroid carcinoma
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Confirmation of the efficacy and the safety about the video assisted surgery for papillary thyroid carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The width of lymph nodes dissection
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 video assisted surgery
Interventions/Control_2 open surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria papillary thyroid carcinoma
Key exclusion criteria poorly or undifferentiated carcinoma
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisato Hara
Organization Tsukuba Univesity Hospital
Division name Department of Breast Thyroid Endocrine Surgery
Zip code
Address 2-1-1 Amakubo Tsukuba Ibaraki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tsukuba University Hospital
Division name Department of Breast Thyroid Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tsukuba University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was no significant difference between the video-assisted group and the non video-assisted group in the comparison of operative time, blood loss, and range of lymph node dissection.  On the other hand, the length of skin incision in the video-assisted group was significantly smaller than those in the non video-assisted group.Video-assisted thyroidectomy and modified radical neck dissection might be an acceptable procedure for the surgery of the papillary thyroid carcinoma.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 27 Day
Last modified on
2012 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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