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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013487
Receipt No. R000015753
Scientific Title Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Date of disclosure of the study information 2014/03/23
Last modified on 2016/09/23

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Basic information
Public title Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Acronym Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Scientific Title Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Scientific Title:Acronym Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Region
Japan

Condition
Condition Graves' disease
Classification by specialty
Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of LigaSure small jaw vessel sealing system in surgery for Graves' disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Operation time
Key secondary outcomes Blood loss, drain output, complications (post-operative hemorrhage, recurrent laryngeal nerve paralysis, hypoparathyroidism ), number of sutures used

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 LigaSure Small Jaw group
Interventions/Control_2 Conventional group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Graves' disease
2)Preserved major organ function
3)Patients providing written informed consent for participation in the study
Key exclusion criteria 1)History of neck surgery
2)Requiring neck lymph node dissection
3)Without Graves' disease
4)Any others judged by the doctor in charge to be ineligible for subjects in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Suzuki
Organization Ito Hospital
Division name Surgery
Zip code
Address 4-3-6, Jingumae, shibuya-ku, Tokyo, Japan, 150-8308
TEL 03-3402-7411
Email af-suzuki@ito-hospital.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akifumi Suzuki
Organization Ito Hospital
Division name Surgery
Zip code
Address 4-3-6, Jingumae, shibuya-ku, Tokyo, Japan, 150-8308
TEL 03-3402-7411
Homepage URL
Email af-suzuki@ito-hospital.jp

Sponsor
Institute Ito Hospital
Institute
Department

Funding Source
Organization Covidien Japan Inc.
Organization
Division
Category of Funding Organization Profit 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
2014 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Main results already published
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 23 Day
Last modified on
2016 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015753

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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