UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013487 |
|---|---|
| Receipt number | 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 15:44:51 |
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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
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
af-suzuki@ito-hospital.jp
Sponsor or person
Institute
Ito Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015753
