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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007137
Receipt No. R000007998
Scientific Title Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy
Date of disclosure of the study information 2012/01/25
Last modified on 2015/01/26

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Basic information
Public title Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy
Acronym Plan Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy
Scientific Title Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy
Scientific Title:Acronym Plan Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy
Region
Japan

Condition
Condition Thyroid cancer
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine whether the study treatment using the LigaSure Small Jaw System is superior to the current standard treatment with vessel ligation using sutures in operating time and other endpoints in a randomized controlled trial conducted in patients undergoing thyroidectomy for thyroid cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Operating time
Key secondary outcomes amount of blood loss, amount of drainage, lymphatic leakage, length of hospital stay, duration of drainage, comparison of medical costs (labor costs, number of sutures used, operating time, etc.), fatigue levels of the operator, incidence of intraoperative adverse events, incidence of postoperative adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 ligation 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients aged 20 years or older
2) Patients scheduled to undergo total thyroidectomy with unilateral dissection for thyroid cancer
3) Patients with no history of similar surgery
4) Patients with preserved major organ function
5) Patients providing written informed consent for participation in the study
Key exclusion criteria 1) Patients requiring concurrent resection of the trachea, etc. due to adjacent organ involvement
2) Patients with active bacterial and/or fungal infections
3) Patients receiving continued systemic (oral or intravenous) steroids
4) Patients with uncontrolled diabetes mellitus (HbA1c >8.0%)
5) Patients with psychiatric disorder or psychiatric symptoms that would preclude the participation in the study
6) 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 Akira Miyauchi
Organization Kuma Hospital, Shinkokai Medical Corporation
Division name Department of Surgery
Zip code
Address 8-2-35, Shimoyamate-dori, Chuo-ku, Kobe City, Hyogo, 650-0011
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kuma Hospital, Shinkokai Medical Corporation
Division name Department of Surgery
Zip code
Address 8-2-35, Shimoyamate-dori, Chuo-ku, Kobe City, Hyogo, 650-0011
TEL
Homepage URL
Email

Sponsor
Institute Kuma Hospital, Shinkokai Medical Corporation
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
2012 Year 01 Month 25 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 Completed
Date of protocol fixation
2011 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 25 Day
Last modified on
2015 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007998

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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